Clinical Project Manager Salary in Cambridge, MA

The Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverables across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patientsHere's What You'll Do:Support study lead programmer to oversee CRO all programming deliverables and milestones from study start-up to study completion, maintaining programming standards and ensuring compliance with SOPs to produce high quality and timely deliverables Serve as a study programming team member and work closely with study lead programmer in all aspects of the development of the Statistical Programming deliverablesParticipate in the review of CRFs and CRF Completion GuideParticipate in the review of SAP and ShellsParticipate in the review of SDTM annotation CRF, SDTM and ADaM specificationsDevelop QC Programs independently to support internal QC for key elementsDevelop programs to support ad-hoc requests-based analysis with no or minimal supervisorCollaborate closely with Study leads, Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Moderna to effectively address their needs for programming support.Participate in the development of CRFs, edit check specifications, and data validation plansCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goalsOversee statistical programming contractors and mentor junior team membersHere's What You'll Bring to the Table:MS or PhD (or equivalent degree) with 3+ years or BS with 5+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizationsMastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPHKnowledge of relevant FDA, EU, ICH guidelines and regulations.Experience working with CROs, vendors, and relationship management preferred.Outstanding communication skills (verbal and written).Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-KF1-

The Role:Moderna is seeking a Clinical Supplies Project Manager to manage the clinical supplies needs across its projects, as well as, work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be skilled at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.Here's What You'll Do:Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessaryParticipate in business review meetings with third party drug supply vendorsAssist in development of IRT requirements, user acceptance testing, and managementAssist with Clinical Supplies Planning and Forecasting as required to meet program objectivesDevelop and compile KPIs (metrics)Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical suppliesManages/Works with third party vendors, Functional Leads and interface with CMC for Production Planning & Distribution; develops forecast of all drug supply needs and works with CMC department to ensure goals are metGenerates and reviews processes as required and ensures compliance to relevant SOPsImplements Industry Best Practices and templates for clinical drug supply activitiesWorks with CMC and clinical group on Master Production Schedule so timing of clinical trial drug needs are metMaintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirementsMonitors and tracks shipments to ensure smooth transit through the logistical path -including international shippingResponsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departmentsOversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolutionDevelop pharmacy manual in conjunction with relevant cross functional leadsDevelop drug supply training materials for investigational sitesHere's What You'll Bring to the Table:At least 3 - 6 years of clinical drug supply management/clinical supply chain/clinical supplies experience in a clinical research environment is preferredBachelor's degree in a science-based subjectPrior Cold Chain packaging, labeling, distribution experience preferredIRT design and management experience preferredClinical Supplies Planning and Forecasting experience requiredExperience with Clinical Supply Inventory Management systems requiredPrior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferredCreative, capable problem-solverExperience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirementsDemonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomesModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-LG1-

Responsibilities:Utilizing company's clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science (Clinical Science Lead, Immunology) on the Clinical Research and Development team, responsible for leading or supporting the design, data collection and clinical studies, reporting activities that comprise the development and design of a clinical drug program/portfolio, to determine the drug's efficacy, based on the interpretation of trial results.Serves on the clinical development team, working collaboratively with the Medical Director(s) to develop the clinical development plan for the designated indication. Responsible for the writing of clinical documents, which may include clinical protocols and associated amendments, charters, safety monitoring plans, process documents, scientific manuscripts and abstracts, posters and scientific presentations, briefing documents, IND reports, clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates and the clinical sections of regulatory submissions to support product approvals, etc.Gathers clinical data ensuring that the clinical development process utilized is aligned with strategic objective(s), as well as regulatory reporting requirements (working with biostatistics and data management). Plan for interim data analyses and reviews. Monitors and evaluates emerging clinical data, reviewing, analyzing and interpreting study data, presenting study-related scientific and medical data as a basis for the development and design of the clinical drug program or portfolio.Selects and develops the clinical outcome measure, completing the data review, and undertaking the subsequent clinical trial activities.Select/liaise with extramural consultants (i.e. Data Safety Monitoring Board and Steering Committees).Reviews and interprets data, producing abstracts, presentations and manuscripts.Contribute to development of the clinical protocol by performing medical literature and new technology reviews, seeking input from various R&D functions.Collaborates with the Medical Director(s), clinical operations, and other R&D organizations to conduct clinical review of the study data; reviewing and discussing the clinical study reporting documentation, and as the studies end, securing the data and completing the study reporting.Collaborates with other functions to: develop and implement the overall data quality plan; to review safety narratives and other safety-related guidelines and documentation, while tracking, analyzing, and reporting any potential safety events.May serve as the study point-of-contact regarding questions associated with an assigned study (ies) or program(s) coming from internal functions, such as clinical operations, or externally from a CRO.Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform, so as to develop a current understanding and outlook regarding internal and/or external influences, and their implication on Immunology studies.Requirements / Qualifications:This position requires a Bachelor's degree, in the Life Sciences, or the equivalent. An advanced scientific degree (e.g., Master's Degree in Science, a PhD or PharmD) is preferred. Possessing a strong scientific background in the therapeutic area of Immunology. Additional expertise in Gastroenterology, Dermatology, Allergy, and Rheumatology preferred.Possesses a strong scientific background, having five to seven years pharmaceutical industry experience in clinical drug development and the associated regulatory processes. Has extensive knowledge in clinical research, understanding the design and management of clinical trials. Previous experience across Phase I-III drug development projects is required, with a focus on Immunology product development. Academic drug development experience will be considered.Demonstrated understanding of and the experience supporting clinical trial design, having been responsible for developing essential documents (such clinical trial protocols, protocol amendments, case report forms, etc.), along with the driving the execution of the clinical study(s).Project planning skills, focusing on realistic, efficient, and effective plans.Utilizing attention to detail, and strong organizational skills, has established a successful track record managing the clinical strategy and the associated study(s), ensuring the necessary data collection documentation is accomplished for the required analysis and interpretation of clinical trial results.Possesses technical expertise and knowledge of Immunology, specifically the drug compound and the emergence of new technologies and advancements in the care of the patient and treatment of Autoimmune diseases, so as to have the credibility to serve as a liaison with internal/external partners (clinical investigators, key opinion leaders (KOLs), medical directors, etc.).Subject matter expert with a strong analytic background, and compelling written and verbal communication skills, capable of presenting clinical data and complex findings to team members and members of senior management/decision makers, as well as external audiences and/or experts.Recognizing the value of working cross-functionally, demonstrated ability to operate collaboratively to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives, maintaining an awareness of regulatory requirements, as well as commercial objectives.Knowledge of regulatory guidelines and standards (GCP, ICH and regulatory agency (FDA) guidelines).Possesses ability to author scientific documents, including documentation supporting regulatory submissions.High performing and able to work independently, organizing priorities and managing project timelines, while possessing the necessary interpersonal skills and strong analytical skills that enable the successful team collaboration so as to accomplish clinical strategy.Ability to read printed materials and written information on a computer screen is required.Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).As a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.This role requires the incumbent to travel based upon the needs of the business, up to 30% of the time.

Industry: BiotechnologyPosition: Clinical Scientist IIILocation: Cambridge, MA (Hybrid: 3 days per week remote)Duration: 12 months contract (+Possibility of extension)Details:This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) and Development Units in company's R&D.The primary purpose of the Clinical Scientist's position is to assist/support the Clinical Research Director in the medical/scientific contribution for the clinical studies e.g: supporting operational activities pertaining to the abbreviated protocol/protocol/amended protocol development (such as contribution to writing of protocol and/or amendments, informed consent, committees charters development and other study ancillary documents), support in the validation and clinical case review of study data, review of study plans and draft study reports/publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, help manage study committees.Scope includes all R&D clinical trials for Riliprubart in CIDP (chronic inflammatory demyelinating polyneuropathy), from scientific assessment of a clinical project to final deliverable. The applicant must be able to use digital reporting tool, convinced and willing to promote their use. The applicant must be a fast learner as the work needs can change and evolve over time based on project progress. The applicant must be familiar with all medical and operational aspects related to the conduct of late-stage clinical trials.Under the guidance of the CRD he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical review, as needed. He/she supports the CRD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.To better serve the activity, and depending on his/her experience, a Clinical Scientist can be dedicated to a specific task with minimal supervision (e.g. answering questions of local teams, managing validation strategy etc...), following business needs.Main Responsibilities:Ensure scientific support for the conduct of Riliprubart study(ies) he/she is allocated to by securing the operationalization of the medical validation/review plan (reports and trackers)Contribute to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved some of the study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to Pharmacovigilance or safety events of special interest)Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form). Participates with the Study Team and monitoring team training on medical informationSupport CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project as neededIs involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of rationalizing and documenting the data collection needs quantitatively and qualitativelyHelp for the preparation, organization, conduct and minutes of Study Committees (eg. IDMC), follow the contracts with business support as neededSupport CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings as neededSupport to regulatory documents filing and archiving.Is assessing, providing cost elements related to the study support in collaboration with study team, including planning management as neededRequired Knowledge and Skills:Understand data collection, data flow, data validation, including medical validation and review processes up to data analysisAble to develop good quality management practices, including guidelines, as regard to medical data review activities, using a data-driven and risk management approachDigital and data orientedScientific expertise or interest and ability to learn in the domain of assigned study/projectAbility to take responsibilities on medical activities or endorse CRD decisions on his/her behalfQuality focused, detail-oriented and well organizedAbility to handle multiple tasks and to prioritizeStrong communication skills (verbal and written)Ability to synthesize the information, good presentation skillsAbility to work autonomously and to efficiently provide status reportsAbility to anticipate and timely escalate issues and to define appropriate action plansTeam and results orientedStrong English skills (verbal and written if English is the second language)Required Education/Experience:MD, Ph.D., Pharm.D., or similarPrevious experience in Clinical Research and/or Drug Development (e.g., at least 5-10 years within pharma industry or CRO or other clinical trial sites).Previous senior clinical experienceMinimum of 5 years of clinic experience, review data, operation, and clinic dataExperience with Quality, deviations, Protocols and consentsMust have experience in late-stage clinical trials, medical monitoring, and data reviewsPrevious experience with medical validations/ reviews/ adverse events Nice To Have/ Preferred:Previous experience in neurology, neuroscienceMedical writing experience (drafting consents or protocols) • Medical safety experience is a plus

Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data ManagementPosition type: Full Time Perm Location: Preferred location Cambridge, MA / Remote Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candidateAs a Manager/Sr Manager, Data Management you will:RESPONSIBILITIES Manage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the team QC each deliverable prior to sending to internal or external clients Prepare and present individual performance reviews Provide mentorship to DM staff and suggest/implement solutions for complex issues Assist staff with interactions with sponsors and managing vendors Keep supervisor updated on study progress and staff management through routine meetings Maintain a positive, progressive, and proactive management style and communication Develop and update data management SOPs and training manuals Conduct data management training as well as study specific training for the CDM and study teams Provide input from the data management perspective regarding the design of clinical trial protocols Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures Oversee and participate in the process of data review and query generation procedures Oversee and participate in the coding of medical terms Oversee/define/perform SAE reconciliation processes Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system Ensure proper completion of UAT of EDC system and modules Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation Review queries and trends to ensure data completeness and integrity Review/prepare training materials and user guides for EDC data collection tools, deliver user training Participate in client and team meetings as required advising on best practices as appropriate Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes Implement technical solutions, new tools, and process improvement strategies Lead large and complex projects Identification of project scope changes Present at sales and marketing meetings for prospective clients Provide strategic input to the department and company goals Lead key departmental goals and initiative EDUCATION Minimum BS in a scientific or health related field or equivalent EXPERIENCE Minimum of 10 years of experience in Clinical Data Management Minimum 2 years supervisory experience is required SKILLS Knowledge of GCPs and regulatory agency guidelines Familiarity with medical terminology is required Skilled in the use of data management software application, Medidata RAVE Excellent organizational and time management skills Strong collaboration and leadership skills Excellent oral and written communication skills Strong interpersonal skills Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you!Preeti Sehgal [email protected] RANGE AND BENEFITS: Pay Range*: $175K - $185K depending on experience and level, might go up on the salary for the right candidate *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Working under general supervision from manager or PI, providing support to clinical research studies. Independently coordinates all activities of clinical trials and clinical research including but not limited to supervising the daily activities of research assistants, implementing, and maintaining quality assurance procedures, designing research protocols, and overseeing and conducting study enrollment and activities. This position is seeking a Senior Research Assistant for clinical trial activities and management.Qualifications PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Serve as team lead to the group of Research Assistants, including guidance and instruction, workflow reassignment as needed. Working with Program Manager and PI to discuss team function and performance.2. In collaboration with PI and Program Manager, develops, implements and/or maintains an orientation and training program for study staff.3. Coordinates the implementation, both internally and externally, of sponsored clinical research studies. 4. Function as a resource for all study issues. Identifies problems and develops solutions, independently or in conjunction with study managers.5. Initiate and maintain contact with study participants, study scheduling, and participant screening. 6. Designs, implements, and evaluates recruitment strategies for study participants.7. Perform applicable tests as per protocol, defined by project role. 8. Interact with patients/subjects regarding study, including patient education, procedural instruction, follow-up. May serve as a liaison between patient and physician.9. Conducting and overseeing the data collection process. Ensures integrity of patient data. 10. Develops, organizes, and/or maintains the study forms. Responsible for data validation and quality control, data entry into CRFs, if applicable. May be required to input data and do minimal analysis and run various reports. 11. Implements and maintains quality assurance procedures and systems.12. In collaboration with PI and manager, develops and implements new research protocols including design, data collection systems, and institutional review board (IRB) approval. 13. Assorted administrative work on participant and regulatory documentation. Address study-related phone calls and emails.14. Maintain study compliance and any IRB and/or FDA reporting.SKILLS/ABILITIES/COMPETENCIES REQUIRED:• Ability to work independently and display initiative to introduce innovations to research study.• Excellent interpersonal skills with patients/participants and co-workers.• Excellent oral and written communication skills.• Strong analytical skills and conceptual thinking. Ability to resolve technical or research problems and issues and to interpret the acceptability of data results.• Ability to prioritize tasks and set deadlines.• Ability to identify problems and develop solutions.• High degree of computer literacy.• Careful attention to detail. • Ability to demonstrate professionalism and respect for subjects' rights and individual needs.QUALIFICATIONS: • BS or BA, equivalent experience, or research certification acceptable as well• 3-5 years of directly related, progressively more responsible, experience.• Supervisory experience preferred.• Experience with phase I-IV clinical trials preferred.• knowledge of medical terminology, clinical practice and/or research studies highly desired.• Sound independent judgment and willingness to learn competence in research methodologies a must.WORKING CONDITIONS:• Working within clinical and dry office space.• Occasional laboratory exposure, no specific duties. • Exposure to biological fluids, i.e. blood, urine, CSF, stool.• No lifting over 25 pounds.SUPERVISORY RESPONSIBILITY:• Responsible for directly supervising Research Assistants in area. • Trains staff, in addition to assisting with hiring and evaluating of Research Assistants. • Coordinates staffing and schedule.EEO Statement BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data ManagementPosition type: Full Time PermLocation: Preferred location Cambridge, MA / RemoteSalary: $175K - $185K depending on experience and level, might go up on the salary for the right candidateAs a Manager/Sr Manager, Data Management you will:RESPONSIBILITIESManage and supervise a team of Clinical Data Managers (CDMs) Oversee each project assigned to the teamQC each deliverable prior to sending to internal or external clientsPrepare and present individual performance reviewsProvide mentorship to DM staff and suggest/implement solutions for complex issuesAssist staff with interactions with sponsors and managing vendorsKeep supervisor updated on study progress and staff management through routine meetingsMaintain a positive, progressive, and proactive management style and communicationDevelop and update data management SOPs and training manualsConduct data management training as well as study specific training for the CDM and study teamsProvide input from the data management perspective regarding the design of clinical trial protocolsOversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock ProceduresOversee and participate in the process of data review and query generation proceduresOversee and participate in the coding of medical termsOversee/define/perform SAE reconciliation processesWork with DM leads and DB programmers to design (e)CRFs and edit checks in EDC systemEnsure proper completion of UAT of EDC system and modulesOversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliationReview queries and trends to ensure data completeness and integrityReview/prepare training materials and user guides for EDC data collection tools, deliver user trainingParticipate in client and team meetings as required advising on best practices as appropriateProvide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studiesProvide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changesImplement technical solutions, new tools, and process improvement strategiesLead large and complex projectsIdentification of project scope changesPresent at sales and marketing meetings for prospective clientsProvide strategic input to the department and company goalsLead key departmental goals and initiativeEDUCATIONMinimum BS in a scientific or health related field or equivalentEXPERIENCEMinimum of 10 years of experience in Clinical Data ManagementMinimum 2 years supervisory experience is requiredSKILLSKnowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVEExcellent organizational and time management skillsStrong collaboration and leadership skillsExcellent oral and written communication skillsStrong interpersonal skillsQualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.Thank you!Preeti SehgalPAY RANGE AND BENEFITS:Pay Range*: $175K - $185K depending on experience and level, might go up on the salary for the right candidate*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)ClearlyRated® Client Diamond Award Winner (2020)One of the Largest Certified MBE Companies in the NMSDC Network (2022)Advanced Tier Services partner with AWS and Gold with MSWebsite: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.Desired Skills and ExperienceEXPERIENCEMinimum of 10 years of experience in Clinical Data ManagementMinimum 2 years supervisory experience is requiredSKILLSKnowledge of GCPs and regulatory agency guidelinesFamiliarity with medical terminology is requiredSkilled in the use of data management software application, Medidata RAVEExcellent organizational and time management skillsStrong collaboration and leadership skillsExcellent oral and written communication skillsStrong interpersonal skillsAmerican Cybersystems, Inc is acting as an Employment Agency in relation to this vacancy.

Company DescriptionAt Biogen, we pioneer in advancing science and strive to drive results whilst effectively managing risk. We are humble and curious and work towards creating a culture of integrity, trust, and treat everyone with openness, care, and dignity. The role of Manager in the Quality Systems & Technology team is aimed to provide quality oversight for computerized systems, technology, and solutions in accordance with GCP and applicable global regulations and Biogen policies and procedures. You will advocate for a risk-based approach to quality management, assess and manage risks as they emerge, and help drive efficiency while also ensuring compliance. You will be expected to build/enhance knowledge of regulatory trends and provide guidance to internal teams relating to the emerging regulations. An understanding of computer system validation and associated regulations combined with competencies in cross collaboration with R&D Quality & Compliance (RDQC), functional leads and IT operations is required.Job DescriptionWhat You'll Do Supporting quality oversight of computer systems and emerging technologies.Participating in process improvements and functional initiatives, as required.Overseeing and approving CAPAs / Effectiveness checks.Understanding of quality by design, risk assessments, quality measures and metrics.Understanding of the principles of data integrity.Supporting and engaging in cross-functional initiatives and ensuring timely execution of defined goals/objectives, including anticipating and identifying project risks, mitigations, and contingencies.Supporting audits and inspections. Supporting closure of regulatory agency commitments and CAPAs specific to systems and technology.QualificationsWho You Are You will have core competencies around project management, quality issue management, process improvement, collaboration and decision making and a thorough understanding of the principles of data integrity, computer system validation and industry regulations. Required Skills Bachelor's Degree required. Master's or Advanced Degree preferred.5-7 years of Clinical Trial/compliance/quality experience working in the biotechnology or pharmaceutical industry.Experience with regulatory inspections.Experience with Quality Management Systems.Must demonstrate extensive knowledge of the principles GCP regulations including data integrity requirements, computer system validation, GAMP 5, medical devices regulations etc.Additional InformationThe base compensation range for this role is $101,600 to $163,700. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bdd7cb8-9029-424f-bee9-9e8b4e8d9a7e

Program Manager - Business Professional5 Month Initial ContractCambridge, MA - Hybrid - onsite 2-3 days/weekMax PR: $94.21 MUST HAVE'sBachelor's Degree in Science or Business | MS preferred Minimum 3 years of PM experience leading complex pharmaceutical projects in a multi-disciplinary, global environmentPM experience in Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other Drug Development related functionSUMMARYAs part of the GMSO Program Management team, you will report to the Strategy & Operations Lead, GastroenterologyROLELeads the program and project planning efforts of MSTs, in maintaining oversight for the operational plans, execution strategies & critical path for the product.Responsible for coordinating governance approvals for the key project deliverables and holds self and team members accountable to deliver on the agreed upon program objectivesManages project and resource priorities that align with the business objectives.Addresses and resolves project challenges, keeping Unit Head/Lead MPM informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.Establishes, communicates and executes plans resulting in achievement of project goalsManages the creation of project strategies and supports the MST in presenting these strategies to key stakeholders and decision makers.Adjusts project strategy and priorities in response to changes in strategic direction.Provides direction and obtains buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.Identifies ways to accelerate the project execution where possible while maintaining high quality standards.Develops strong logistical skills to manage activities across functions and regionsFacilitate the MST and/or other group meetings and/or other group meetings and ensure agendas are appropriate to enable key discussions and decisions within the team.Manage the planning, operational and reporting logistics of the MST (including but not limited to: meeting schedule management, meeting facilitation, development of meeting materials with contributors, capture and follow up of action items and deliverables, distribution of minutes and maintenance of relevant SharePoint site (or equivalent))Responsible for building quality relationships with key stakeholders, in both TAU and Commercial, that result in valued and trusted partnerships and program support.Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution, ensuring that MST arrives at a singular conclusion or recommendationsProvides financial oversight for program budget. Includes consolidation, vetting and prioritization of MST spending/ vendors, risks and opportunities, in partnership with the GMUH and in collaboration with GMA functional teams.Leads the project risk management process in the team and generates the cross-functional project risk register for assigned MSTs. Ensure that the risks identified for GMA activities at the MST are reported up through to the Global Program Manager at the GPT for consolidation into the Global Risk Management Plan for the asset.Works closely with the MST cross functional team members to balance operational execution with GMA strategy.Manages project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates.Generates collaboration, cooperation and communication globally across divisions and functions and between regional representatives in the team ensuring that team goals are achieved.Education & Qualifications Bachelor's Degree science or business-related field (Masters preferred) (PHD acceptable)At least 3 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environmentKnowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related functionKnowledge of the drug development and commercialization process and an understanding of the functions within the pharmaceutical industryProven ability to communicate clearly and present key information objectively and collaborate effectively with managementExperience managing program level budgets across multiple projectsKnowledge of regulatory and compliance guidelines governing medical affairsApplied knowledge of performance measurement (e.g. metrics, dashboards)May travel to the US, EU and other meeting locations internationally. Approximately 5-10% travel may be required (will confirm about travel / may not be required)

The Role:Moderna is seeking a Manager, Clinical Supplies Planner to manage the clinical drug supply planning and forecasting needs across its clinical projects. This position will work collaboratively across several therapeutic area teams as well as cross functionally to gather relevant information and utilize relevant systems to create study supply plans, forecast study drug supply, and provide delivery timelines and budgets. The successful candidate will be skilled at understanding the needs of programs with attention to detail with a collaborative outlook and with the ability to manage workload to meet project timelines. Here's What You'll Do:Manage systems management as required to support the clinical supply chainSupport end-to-end supply planning, from bulk drug product through finished good availabilitySupply and Demand Planning: Utilize simulation and forecasting tools to create and revise clinical supply and demand plans, integrating insights from Clinical Operations. Collaborates with CMC, clinical operations, and project management to ensure timing of clinical trial drug needs are metInterface with CMC for Drug Product & Production Planning; including expiry managementReviews processes as required and ensures compliance to relevant SOPsImplements Industry Best Practices for clinical drug supply activitiesMaintains collaborative relationships with internal stakeholders (i.e., Supply Chain, Quality, Manufacturing) to assure the complete scope of planning activities remains connected with operations and compliant with quality requirementsMonitors and tracks shipments to ensure smooth transit through the logistical path -including international shippingContribute to demand planning cycle within Clinical Development OrganizationHere's What You'll Bring to the Table:At least 5 years of clinical supply management experience in a clinical research environmentBachelor's degree or similar industry experiencePrior Cold Chain distribution experience requiredExperience with forecasting solutions and tools preferredPrior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferredCreative, capable problem-solverExperience in establishing and maintaining relationships with vendorsWorking knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirementsDemonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, Teams, SharePoint and Smartsheet's)Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomesModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-JL3-