Senior Clinical Project Manager

TalentBurst•Marlborough, MA

1d•Remote

About The Position

The Senior Clinical Project Manager provides operational oversight of Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Programs (EAP). The role covers study planning, execution, monitoring, and closeout, while coordinating across internal functions and external research partners. It serves as a key operational contact for investigators and supports study progress, risk management, regulatory compliance, financial tracking, and scientific deliverables. The position also contributes subject matter expertise, process improvement, and guidance for IIS, Collaborative Research, and Expanded Access activities. This is a remote role with the client location in Massachusetts. The 6–7 month assignment is for leave-of-absence/PTO coverage.

Requirements

Proven leadership skills, executive presence, maturity, emotional intelligence, and written and oral communication skills.
Demonstrated ability to work in a matrix environment.
Ability to collaborate with internal and external partners, including investigators, CROs, vendors, and team members in the parent company in Japan.
Interpersonal skills and influence to accomplish work without formal authority and support optimal team performance.
Minimum of 3–5 years of industry experience in clinical drug or program development, or equivalent academic experience in clinical trials.
Strong experience facilitating project team meetings, cross-functional communication and decision-making, and alignment with internal and external stakeholders.
Strong attention to detail and ability to establish priorities, schedule work, and meet deadlines.
Sound judgment, problem-solving, leadership, and collaboration skills in selecting methods and techniques to resolve problems.
Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas.
Experience evaluating clinical trial outcomes and basic knowledge of clinical trial outcome standards.
Strong analytical skills and a data-driven approach to planning, execution, and problem-solving.
Working knowledge of current global regulatory requirements and guidelines for clinical trials.

Nice To Haves

BS, MS, or PhD in a related life science discipline.
Thorough understanding of the oncology arena.

Responsibilities

Provide operational oversight of IIS, Collaborative Research, and EAP portfolios, including study planning, execution, monitoring, and closeout.
Lead cross-functional collaboration with Medical Affairs, Clinical Operations, Research & Development, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, Clinical Business Operations, and other relevant functions.
Serve as an operational point of contact for investigators and external research partners, fostering productive relationships with internal stakeholders, the parent company, and relevant affiliates.
Monitor study milestones, patient enrollment, timelines, study drug accountability, contractual obligations, and deliverables.
Identify study risks and operational issues, develop mitigation and contingency plans, and escalate significant issues or cross-functional misalignment as appropriate.
Drive cross-functional alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps.
Work with Clinical Supply and stakeholders to assess enrollment projections, study drug requirements, supply availability, expiration considerations, and supply risks.
Collaborate with Clinical Business Operations, Finance, Legal, and investigators to negotiate and finalize Clinical Trial Agreements and study budgets, as applicable.
Monitor study budgets and track contractual milestones, deliverables, payments, and other financial obligations; support resolution of budget, invoicing, and payment issues.
Prepare and review study-related documents and correspondence and ensure required documentation is maintained and retained.
Participate in Study Team Meetings, Investigator Meetings, and other study-related meetings as appropriate.
Prepare and deliver portfolio and study updates to Medical Affairs, cross-functional stakeholders, and leadership.
Confirm study deliverables are completed in accordance with contractual requirements.
Coordinate receipt and internal review of investigators’ manuscripts, abstracts, presentations, and other scientific deliverables, including applicable legal, intellectual property, and safety considerations.
Support CyberGrants Portal submissions and serve as backup to the Administrator.
Ensure assigned studies comply with applicable regulations, internal requirements, contractual obligations, and procedures; provide study-specific expertise and documentation support during regulatory inspections or audits as applicable.
Lead or contribute to the development, review, implementation, and continuous improvement of SOPs, processes, tools, templates, and workflows supporting IIS, Collaborative Research, and Expanded Access activities, including related training.
Maintain knowledge of oncology, current medical practices, and applicable pharmaceutical regulations.
Serve as a subject matter expert for IIS, Collaborative Research, and Expanded Access operational processes, and provide guidance, knowledge sharing, and mentorship as appropriate.
Perform other duties and responsibilities as requested by senior management.