Clinical Project Manager Salary in State of Wyoming, USA

The Program Manager Lead (PL) is responsible for program management and strategic leadership in partnership with the Clinical Development Lead, and will drive short-term and long-term program strategy, goals and plans for the assigned asset. The successful candidate will integrate experience and knowledge in program management, clinical development and finance to manage research programs and deliver key milestones for a high-profile asset. This is role reports directly to the Head of Clinical Development.Responsibilities may vary according to business priorities, but may include:Partner with the clinical development lead in leading the matrixed team through an evaluation of the viability of the program, integrating scientific, regulatory, and commercial considerations. Drive execution of plans and critical decision-making. Track progress against project plans and ensure team deliverables are met on time and on budget. Assist teams to appropriately navigate urgent situations.Manage and lead cross-functional meetings, including scheduling meetings and managing attendee list; creation, distribution, and archiving of meeting agendas and minutes; meeting facilitation; and driving completion of action items. Minutes should document a record of events including important scientific discussions and rationale for key decisions.Drive the completion of two or more scientific and medical advisory boards in 2024 to develop robust Go/No-Go criteria and to evaluate data from a proof-of-concept study. Tasks may include recruiting external advisors, assisting with contracting and scheduling, developing and critically reviewing materials (e.g. pre-meeting surveys, presentation decks, agendas, minutes, executive summaries). Facilitate the development of clear, prospective Go/No-Go decision points and serve as a credible leader for the program. Review and analyze data objectively and collaborate with the matrixed team to highlight opportunities, address potential risks, and proactively provide appropriate mitigations.Has or develops a solid understanding of the disease state, standard of care, and competitive landscape for the assigned asset, through interactions with team members and reading the medical literature.Prepares presentation decks or executive summaries of recommendations for presentation to senior management. Develop communication plans for key decisions or data readouts to senior management.Interact in a professional manner with external stakeholders, including corporate development partners, external consultants, academic research collaborators, and patient advisors, to support the clinical development plan and the scientific communication and publication strategy.We are looking for professionals with these required skills to achieve our goals:Bachelor's Degree with at least five years of industry experience in a scientifically relevant field; Advanced degree highly preferred (e.g. Masters degree or PhD).Relevant experience in a pharmaceutical/biotech setting, preferably in translational or clinical development. Experience with rare disease or biologics is an asset.Ability to assimilate new knowledge rapidly and apply that to asset strategy.Demonstrated experience managing complex projects and exhibiting strategic thinking. Polished skills in influencing, communicating, problem-solving, and working collaboratively with diverse stakeholders in a matrixed environment. Willing to skillfully challenge team members and manage conflict, to facilitate comprehensive team assessment of opportunities, risks, and mitigations.Adaptable team player able to work independently, exhibit sound judgement, and hold self and team members accountable in meeting timelines.Excellent written and oral presentation skills.This is a 0.5 FTE role that is based in Boston. Remote candidates will be considered. Occasional travel within the U.S. (estimated 1-3 trips) may be required.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. 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™

Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition. This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making. Essential Functions Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution Represent regulatory on cross-functional teams Process, interpret and provide recommendations for complex strategies Provide regulatory and technical expertise to cross-functional teams Critically review documentation for regulatory submissions and provide input for necessary revisions Develop and implement regulatory strategies for CMC aspects of drug development and registration Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration Serve as Liaison for third party service providers Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards Supports the professional development of regulatory staff through mentorship and guidance Present to upper management at required intervals and effectively communicate successes and challenges Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.) Requirements Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities. Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience. Two years of supervisory experience of direct reports required, matrix management experience preferred. In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices. Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority. Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports. Preparing for and executing Health Authority meetings. 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™

Summary of Position The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity (NCE) as well as products already in non-clinical and/or clinical studies. This position will have a secondary focus on existing marketed products or those obtained through acquisition. This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making. Essential Functions Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution Represent regulatory on cross-functional teams Process, interpret and provide recommendations for complex strategies Provide regulatory and technical expertise to cross-functional teams Critically review documentation for regulatory submissions and provide input for necessary revisions Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration Serve as Liaison for third party service providers Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards Supports the professional development of regulatory staff through mentorship and guidance Present to upper management at required intervals and effectively communicate successes and challenges Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.) Requirements Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience. Two years of supervisory experience of direct reports required, matrix management experience preferred. Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority. Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports. Preparing for and executing Health Authority meetings. 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™

PT Clinical Reviewer Are you looking for an impactful role where you finish the workday knowing you helped someone? Whether you're joining our care coordination team or playing a supporting role, the work you do every day helps us collectively reach our mission of "getting people the care they need when they need it." We believe that by staying committed to our core values of Think Big, Go Fast, Deliver Awe,and Win Together, we can positively impact the lives of the injured workers we serve and get them back to the things that matter most in life. Salary Range: $66100 - $109100 Salary This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At One Call, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $66100 - $109100 SalaryBenefits Summary: In return for your commitment to our company's mission, we offer a vast array of benefits to help support the whole you. • Opportunities to work from home • Competitive wages with opportunities to earn annual merit increases • Paid development hours to use for professional and community development! • 18 days of Paid Time plus 8 company holidays, and 2 personal days per year • $1,000 Colleague Referral Program • Enterprise Recognition Program rewarding colleagues for their extraordinary work • Exclusive discounts on travel, activities, and merchandise via work discount program • Colleague Assistance Program that provides free counseling and financial services • Tuition Reimbursement Program including certifications • Quantum Health: A healthcare navigation platform to help our colleagues make the best, most cost-effective healthcare decisions • Medical, dental, and vision insurance • Pre-Tax FSA and HSA health savings accounts • 401(k) matching • Company paid life insurance • Company paid short term and long-term disability • Healthcare concierge • Pet Insurance • The One Call Foundation which aims to help colleagues during unexpected emergencies, from car accidents to natural disasters. JOB SUMMARY:Responsible for completing clinical QA audits and/or plan of treatment reviews specific to their licensure and scope of practice. Reviews to provide recommendations related to the medical necessity for ongoing care, progression of treatment, appropriateness of past treatments, and billing accuracy. The Clinical Reviewer's primary stakeholder is the client (Adjuster/NCM) and must ensure their review/explanation assists and does not hinder the client from making the best decision on how to proceed with the file regardless of their opinions on the treatment that should be performed. Also responsible for providing clinical expertise and collaboration on other One Call processes and customer issue resolutions.Physical Therapy Clinical Reviewer IMinimum bachelor's degree (B.A. or B.S.) and current physical or occupational therapy license and practiced for a minimum of 5 years within an outpatient orthopedic setting. Worker's compensation treatment experience strongly preferred but not required. Entry level reviewer role. Demonstrates strong clinical knowledge and experience to apply to clinical review/QA. Generally, performs standard Clinical QA reviews. Works under supervision of Clinical Review Supervisor, but with latitude to make independent clinical recommendations. Consults with senior peers and team leads on non-complex issues to learn through experience. Can talk with treating practitioners and network providers about standard One Call clinical program features and benefits. Understands appropriate communication protocols and standard workers compensation workflows from a treating practitioner perspective. GENERAL DUTIES & RESPONSIBILITIES:Review Evaluations, plan of treatments, progress notes, and other clinical documentation and provide a report of clinical guidance to client within 48-72 hours of request, dependent on type. Responsible for calling the treating provider to discuss findings and recommendations, with the goal of securing mutual agreement, and to coordinate communication to patient and MD of any revised plan of treatments. May be responsible for calling client to discuss authorization and/or follow up on Plans of Treatment, continuation of care, or other clinical treatment recommendations. Responds to the financial team's requests within 48 hrs. to assist in processing claims received. Acts as a resource for other staff, answering questions and giving guidance when needed on clinical questions within their scope of practice. Collaborates with Operational leaders to share opportunities for improvement with referral data quality. Works all special reports distributed by a supervisor/manager. Reviews and responds to any requests from clients, provider, claimant, or supervisor and performs necessary action steps within 48 hrs. Consistently demonstrates a positive attitude and an overall commitment to excellence and is a team player. Actively participates in continuous operational improvements. Specific activities include, but are not limited to, offering feedback to management related to process, working closely with provider development team to address provider issues, collaborating with financial team to improve efficiency and participates in training/mentorship initiatives. Assists in obtaining necessary clinical documentation from provider as needed. Is open to coaching and willing to find more efficient processes when applicable. Performs miscellaneous tasks and projects as assigned by management. Demonstrates knowledge of CPT and ICD9/10 codes Reviews and corrects in-accurate coding on referral. Assists in provider appeals related to authorization or payment as needed and related to clinical determination. Participates in provider scoring and complaint review as requested. Utilizes and maintains general knowledge of insurance reimbursement and specific knowledge of One Call Care Management processes. Participates in staff meetings, office presentations, training, orientation, and conference calls, as directed. May participate internal file QA to ensure appropriate care coordination internally. Can always maintain professional composure and demeanor with both internal and external communications and interactions, including discussing modified/reduced treatment with our providers.EDUCATIONAL AND EXPERIENCE REQUIREMENTS:Minimum bachelor's degree (B.A. or B.S.) and current physical or occupational therapy license and practiced for a minimum of 5 years within an outpatient orthopedic setting. Worker's compensation treatment experience strongly preferred but not required.GENERAL KNOWLEDGE, SKILLS & ABILITIES: Ability to read, analyze and interpret a vast variety of both handwritten and electronic medical reports, professional journals, newsletters, technical procedures, and/or government regulations. Ability to write business correspondence and completion of business forms. Ability to effectively present information and respond to questions from colleagues, Adjustors, Nurse Case Managers, Providers and Provider's office staff. Ability to create and utilize Microsoft Word documents and Excel spreadsheets. Ability to define problems, collect data, establish facts, and draw valid conclusions. Must have the ability to work with and have knowledge of the physician community, managed care, pre-certification, and utilization review. Must have knowledge of workers' compensation. Must be able to collaborate with individuals at all levels of the organization. Knowledge of the Internet and how to research information is preferred. Must be able to maintain a professional appearance and exhibit strong interpersonal, verbal, and written communication skills for both internal and external customers, including discussing modified/reduced treatment with our providers. Must be able to organize work to ensure tasks are completed in a timely manner. Ability to respond to common inquiries or complaints from customers. To perform this job successfully, an individual should have knowledge of Microsoft Word; Microsoft Works; Microsoft Excel; Microsoft Internet Explorer; and Microsoft Outlook. Confidentiality of One Call business intellectual property and information Current Physical or Occupational Therapy license required, license must be in good standing with Office of Inspector General (OIG) and National Provider Database (NPDB). One Call may check licensure at time of employment and at discretion at any time during employment. Maintain licensure and provide One Call annual proof of compliance. Maintain ongoing Continuing Education Units (CEUs) as required under personal licensure. Must be licensed in the US.PHYSICAL/EMOTIONAL DEMANDS & WORK ENVIRONMENT:For roles located in office or home settings; this job is primarily sedentary and may involve repetitive motions; the employee is regularly required to sit, use hands and fingers, speak, and hear. The employee is occasionally required to lift objects (up to 10lbs weight; up to 4 ft. height). Specific vision abilities required by this job include ability to see things from a close distance and to adjust focus. The emotional demand of the job may cause undue stress from, but not limited to, moderate/heavy workload. Reasonable accommodations will be individually assessed and possibly made to enable individuals with disabilities to perform the essential functions of the position. Please be advised this job description is subject to change at any time.