Clinical Project Manager
Telix Pharmaceuticals Limited
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Tech Stack
About the role
- Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies
- Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
- Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team.
- Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
- Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
- Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs
- Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues
- Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development/revision, data collection, patient safety/AE management, document management, statistical analysis/final report writing, and study close out.
- Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects
- Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
- Perform any other tasks/duties as assigned by management
Requirements
- Bachelor’s degree in life sciences
- At least 2 years of relevant experience in Clinical Trial Project Management
- Strong understanding of all aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred.
- Ability to deal with multiple priorities with aggressive timelines.
- Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes.
- Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills.
- Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites.
- Fluent in Microsoft Office products (Word, Excel, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF).
- Regional start-up experience (site feasibility, ethics & regulatory submissions)
- Demonstrated ability to pivot study strategy quickly and lead teams in the right direction working in a fast-paced environment.
- Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials.
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 managementrisk managementstatistical analysisdata collectionproject financialsclinical trial protocolsinformed consent formsinvestigator's brochurelaboratory manual
Soft Skills
problem-solvingorganizational skillsplanningdecision makingnegotiationconflict managementrelationship buildingability to manage multiple prioritiesadaptabilityleadership