Clinical Trials Manager Salary in Alabama, USA

Job DescriptionSummarized Purpose: Manages the day to day activities, performance and supervision of the research site. Ensures execution of site protocols and providing daily direction to the site's staff. Acts as the liaison between the investigator and the research team and ensures the execution and coordination of clinical research activities according to the organization's SOPs, ICH/GCP and FDA guidelines. Supports the global aligned business objectives, growth, delivery of targets, quality management as well as the appropriate planning and coordinating of resources and facilities.*This position is located full onsite at our Birmingham, Alabama facility. Relocation assistance is possible for this opportunity*Essential Functions and Other Job Information: • Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.• Manages site activities to ensure delivery of site targets as received from senior management.• Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.• Responsible for cost efficiencies within the site and all vendor contracts for services at the site.• Continuously oversees the schedules of site staff to ensure highest utilization of all resources.• Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.• May provide input in the feasibility process, considering both recruitment and operational concerns.• Communicates targets to the site teams and continuously measures progress.• Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.• Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.• Ensures patient recruitment activities are adequate for study requirements.• Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).Policy & Strategy: Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility. Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.Freedom to Act: Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks.Liaison: Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.Qualifications: Education and Experience:• Bachelor's degree or equivalent and relevant formal academic / vocational qualification• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).• 1+ year of leadership responsibility In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:• Advanced computer skills with proficiency in Microsoft office and content management software and the ability to learn appropriate software/hardware (i.e. EDC, eCRF and possibly IT/SQL skills but not essential)• Strong attention to detail• Good problem-solving abilities• Good organizational and time management skills• Excellent oral and written communications skills• In-depth perspective and knowledge to represent IGC on task forces or teams • Demonstrated ability to analyze data, determining root cause of deficiencies and providing recommendations for resolution• Skilled in leading process improvement activities• Ability to successfully mentoring and training junior staff• Proficiency in the review and analysis of audit reports• Effective coaching and counselling skills• Ability to read, understand and interpret a protocol• Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations• Strong communication skills and business acumenManagement Role: Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department. Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.Working Conditions and Environment:• Work is performed in an office environment with exposure to electrical office equipment.• Frequently drives to site locations and frequently travels both domestic and international.Physical Requirements: • Frequently stationary for 6-8 hours per day.• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.• Moderate mobility required.• Occasional crouching, stooping, bending and twisting of upper body and neck.• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.• Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.• Ability to apply basic principles to solve conceptual issues.• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.• Regular and consistent attendance.Percent Billable: 80% - 100%#LI-RK1

Beacon Hill Life Sciences is actively recruiting for a Senior Manager of GCP Quality Assurance to work a contract assignment, part-time hours. Hours: Part-time, approximately 20 hours per weekDuration of assignment: 6 months with possibility of extensionFully remote is possible, preference is hybrid (Location: Cambridge, MA)Pay Rate is based on experience with range being $100 - $125/hourSummary: The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities. Will be Subject Matter Expert in GCP Compliance with respect to planning, execution, and close-out Clinical Studies.Responsibilities include: Oversight of ongoing compliance of Clinical Studies. Act as GCP QA Program Lead while working with internal customers to ensure overall compliance from risk-based principles. Work with internal and external GCP customers and develop and execute strategic plans to identify, mitigate, monitor and report study risks and Quality Tolerance Limits on a per study basis. Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.GCP Vendor Audits and Oversight. Support the GCP Vendor Audit Schedule including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization liaising with QA Vendor Auditing. Coordinate with Study Team members to ensure vendor audits are appropriately scoped and that third-party auditors are provided all the documentation and insights required for successful audit execution. Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and executed properly.Clinical Investigator Site Audits. Manage the Clinical Investigator (CI) Site Audit program for assigned studies. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped and audit planned. Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and track to closure. Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate.Quality Management System. Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities. Perform internal audits of processes and functional areas to ensure compliance with GCP, internal SOPs and other applicable regulations. Coordinate with Senior Management, Functional Area Leads, and third-party vendors, to plan and execute resolution to compliance gaps identified during mock inspections.Candidate Requirements:Bachelor's degree in the Life Sciences with 7+ years in pharmaceutical or biotech drug development. Advanced degree preferred.Minimum 3 years of experience in Clinical QA. Experience in auditing both Vendors and Clinical Investigator Sites a plus. Experience helping with phase 3 registrational study preferred. Demonstrated experience working with clinical trial teams.Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting.Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.Experience helping with phase 3 registrational study preferred.Must be organized and ability to multi-task with multitude of different pieces.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™

Beacon Hill Life Sciences is actively recruiting for a Clinical Project Manager to work a contract assignment, fully remote. Duration of assignment is at least 7 months, with possibility of extension.Pay Rate is based on experience with range of $90 - $100/hour.Assignment is fully remote, however must work east coast hours.Work Schedule: Full-time, east coast time.Travel may be required (10-20% of the time).The ideal candidate should have the following experience: Must have several years of Clinical Project Management experience and being held accountable for the health of the studies.Must have managed at least 1-2 studies, likely either in maintenance or close-out.Must be able to work independently, however must have a good understanding of when to escalate issues and when to ask questions if unsure of something.SUMMARY:The Clinical Project Manager will be responsible for operational aspects of planning, implementation, execution, and management of one or more clinical research studies. ensuring clinical trial is completed within established timelines and of the highest quality.Oversee management of CROs, and third-party vendors to ensure work performed is in accordance to the Statement of Work and within the approved budget. Authors, reviews, and approves various study related documents and plans. Proactively evaluates study risks and works cross functionally to implement solutions and mitigations as required. Responsible for the financial management of assigned studies and develops and oversees study timelines in coordination with cross-functional team, COL, and Program team. Ensure inspection readiness from a global level by engaging trial team(s) and other stakeholders, with a focus on the Trial Master File (TMF) and general clinical preparedness. Responsible for ensuring that inspection lessons learned are captured and shared. Ability to appropriately escalate issues that are unresolvable at a study team level to the COL and other leadership as applicable.QUALIFICATIONS:Bachelor's degree or nursing qualification is required. Scientific/health care field preferred. Exceptions can be made for individuals with multiple years of experience in Clinical Operations.Experience (6+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization.Strong knowledge of clinical research processes and clinical research terminology.In-depth knowledge of ICH-GCP guidelines and local regulations.Knowledge of regulatory requirements and guidelines governing clinical research.Superior organization skills.Strong attention to details in composing and reviewing/editing materials.Excellent analytical and problem-solving skills.Ability to establish priorities, scheduling, and meeting deadlines.Strong written, oral communication and presentation skills and ability to present at Team meetings. Ability to reason independently and recommend specific solutions in clinical settings.Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands under tight timelines.Demonstrated leadership skills.Ability to work successfully within a cross-functional team.Ability to effectively interact with investigators, vendors, peers, and leadership.Strong aptitude with relevant technology platforms (e.g., eTMF, EDC, CTMS, IRT/IVRS) and project management software programs.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com . We look forward to working with you!Beacon Hill. Employing the Future™