Senior Clinical Project Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Supervise Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs.

• Provide operational management throughout study planning, implementation, monitoring, and closure.

• Facilitate cross-functional collaboration with Medical Affairs, Clinical Operations, R&D, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, and other departments.

• Act as the operational point of contact for investigators and external research collaborators.

• Track study milestones, enrollment, timelines, study drug accountability, contracts, and deliverables.

• Identify study risks and operational challenges; create mitigation and contingency plans while escalating significant concerns.

• Promote consensus on study requirements, timelines, responsibilities, risks, decisions, and subsequent actions.

• Evaluate study drug needs, supply availability, expiration considerations, and supply risks.

• Negotiate and finalize Clinical Trial Agreements and study budgets.

• Monitor budgets and oversee contractual milestones, deliverables, payments, and financial commitments.

• Prepare and manage study documents and correspondence.

• Participate in study team and investigator meetings.

• Prepare and present portfolio and study updates to stakeholders and leadership.

• Coordinate internal reviews of manuscripts, abstracts, presentations, and other scientific outputs.

• Assist with CyberGrants Portal submissions and serve as a backup administrator.

• Ensure studies adhere to regulations, internal standards, contracts, and procedures.

• Support regulatory inspections and audits.

• Lead or assist in the development and continuous improvement of SOPs, processes, tools, templates, and workflows.

• Provide training on relevant procedures.

• Maintain knowledge of oncology and pharmaceutical regulatory requirements.

• Serve as a subject matter expert, offering guidance, knowledge sharing, and mentorship.

• Carry out other tasks as assigned by senior management.

⛳️ Requirements

• A BS, MS, or PhD in a relevant life science discipline is preferred.

• Comprehensive understanding of the oncology field.

• At least 3-5 years of industry experience in clinical drug or program development, or equivalent academic experience in clinical trials.

• Demonstrated leadership capabilities, executive presence, maturity, emotional intelligence, and strong written and oral communication skills.

• Proven ability to operate effectively within a matrix environment.

• Capacity to collaborate with investigators, CROs, vendors, and parent-company team members in Japan.

• Strong interpersonal skills and the ability to influence outcomes without formal authority, ensuring optimal team performance.

• Significant experience in facilitating project team meetings, fostering cross-functional communication and decision-making, and ensuring stakeholder alignment.

• Keen attention to detail with the ability to prioritize tasks, schedule effectively, and meet deadlines.

• Sound judgment and problem-solving skills, showcasing leadership and collaboration when selecting methods for solutions.

• Familiarity with the design and execution of clinical trials and project management in pertinent therapeutic areas.

• Experience in evaluating clinical trial outcomes and basic knowledge of clinical trial outcome standards.

• Strong analytical abilities with a data-driven approach to planning, execution, and problem-solving.

• Working knowledge of current global regulatory requirements and guidelines for clinical trials.

🏝️ Benefits

• 7 Months Contract