Senior Clinical Project Manager
Telix Pharmaceuticals Limited
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- 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 & trial process’ 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
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 demonstrates 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, organisational, planning, decision making, negotiation, and conflict management skills.
- Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in 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))
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial project managementstudy management planspatient recruitment strategiescontract negotiationsbudget managementrisk managementproblem solvingvendor managementstudy protocol developmentquality standards implementation
Soft Skills
communication skillsorganizational skillsanalytical skillsdecision makingnegotiation skillsconflict managementleadership skillsteam oriented mindsetmentoringindependent work
Certifications
Bachelor’s degree in life sciencesPMP certification