Senior Clinical Project Manager

Role Summary

The Senior Clinical Project Manager (SCPM) oversees the execution of national and global clinical trials from protocol conception through the clinical study report, including all project documentation, budget, safety, quality, and team management. The role reports to the Senior/Director of Clinical Operations and requires problem solving, critical thinking, teamwork, and flexibility to deliver study milestones. You will be supporting the international roll-out of Telix’s approved prostate cancer imaging agent and helping advance late clinical-stage products addressing unmet needs in oncology and rare diseases.

Responsibilities

• Proactively managing 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.
• Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards.
• Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
• Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs.
• Managing risks proactively and leading problem solving and resolution efforts
• Support the development and maintenance clinical SOPs and trial processes as required.
• Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach.
• Management of 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 mentor for CPMs
• Work independently with limited supervision
• Attend medical conferences and represent clinical operations through investigator engagement and/or presentations

Qualifications

• Required: 5+ years of relevant experience in Clinical Trial Project Management
• Required: Thorough knowledge of ICH GCP and regulatory processes
• Required: Experience managing global clinical trials
• Required: Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines
• Required: Team-oriented mindset and demonstrates ability to work with cross-functional teams
• Required: Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills
• Required: Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA))
• Required: Proficiency with Microsoft Office suite (Word, Excel, SharePoint, Teams) and experience in an electronic records environment
• Required: Demonstrated leadership skills and ability to cultivate development of others
• Preferred: PMP certification
• Preferred: Experience with late phase clinical trials (Phase 3–4, registration trials)
• Preferred: Oncology and/or radiopharmaceutical experience

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

Education

• Bachelor’s degree in life sciences
• PMP certification (preferred)