Senior Clinical Project Manager
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Job Description
Senior Clinical Project Manager overseeing oncology Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs. Coordinating clinical operations, budgets, regulatory compliance, and cross-functional stakeholders.
Responsibilities:
- Oversee Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs
- Provide operational oversight across study planning, execution, monitoring, and closeout
- Lead cross-functional collaboration with Medical Affairs, Clinical Operations, R&D, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, and other functions
- Serve as operational point of contact for investigators and external research partners
- Monitor study milestones, enrollment, timelines, study drug accountability, contracts, and deliverables
- Identify study risks and operational issues; develop mitigation and contingency plans and escalate significant issues
- Drive alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps
- Assess study drug requirements, supply availability, expiration considerations, and supply risks
- Negotiate and finalize Clinical Trial Agreements and study budgets
- Monitor budgets and track contractual milestones, deliverables, payments, and financial obligations
- Prepare and maintain study documents and correspondence
- Participate in study team and investigator meetings
- Prepare and deliver portfolio and study updates to stakeholders and leadership
- Coordinate internal review of manuscripts, abstracts, presentations, and other scientific deliverables
- Support CyberGrants Portal submissions and serve as backup administrator
- Ensure studies comply with regulations, internal requirements, contracts, and procedures
- Support regulatory inspections and audits
- Lead or contribute to SOP, process, tool, template, and workflow development and continuous improvement
- Provide training on applicable procedures
- Maintain oncology and pharmaceutical regulatory knowledge
- Serve as a subject matter expert, provide guidance, knowledge sharing, and mentorship
- Perform other duties requested by senior management
Requirements:
- BS./M.S./Ph.D. in a related life science discipline is preferred
- Thorough understanding of the oncology arena
- Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials
- Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills
- Demonstrated skills working within a matrix environment
- Ability to work collaboratively with investigators, CROs, vendors, and parent-company team members in Japan
- Interpersonal skills and influence to accomplish work without formal authority and ensure optimal team performance
- Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring stakeholder alignment
- Strong attention to detail and ability to establish priorities, schedule, and meet deadlines
- Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions
- 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 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
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