Senior Clinical Project Manager

About the role

You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations and is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork, and flexibility are vital to success.

Responsibilities

• Proactively manage all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout.
• Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift.
• Independently develop integrated study management plans with the core project team.
• Develop and manage all study-related documents such as study protocol, informed consent, clinical manuals, and implement quality standards.
• Monitor all work performed by external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
• Ensure effective project plans are in place and operational for each trial within trial-appropriate SOPs.
• Manage risks proactively and lead problem-solving and resolution efforts.
• Support the development and maintenance of clinical SOPs and trial processes as required.
• Develop project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed-upon approach.
• Manage complex multi-national, multi-center clinical research projects.
• Develop patient recruitment strategies.
• Conduct contract and budget negotiations with sites and vendors.
• Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders.
• Train study team members and act as a mentor for Clinical Project Managers (CPMs).
• Work independently with limited supervision.
• Attend medical conferences and represent clinical operations through investigator engagement and/or presentations.

Requirements

• Bachelor’s degree in life sciences required; PMP preferred.
• 5+ years of relevant experience in Clinical Trial Project Management required.
• Experience with late-phase clinical trials (Phase 3-4, registration trials), oncology, and/or radiopharmaceutical experience preferred.
• Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
• Team-oriented mindset and ability to work with cross-functional teams.
• Experience managing global clinical trials.
• Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.
• Demonstrated ability to pivot study strategy quickly and lead teams in the right direction.
• Strong analytical, organizational, planning, decision-making, negotiation, and conflict management skills.
• Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in a mainly electronic record-keeping environment.
• Demonstrated leadership skills and ability to cultivate development of others.
• Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions: APAC, EMEA, NA).
• 10% travel to be expected.

Skills

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.

Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.