Clinical Project Manager

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to improving the quality of life for people living with cancer and rare diseases. The Clinical Project Manager will oversee the day-to-day responsibilities of multiple early phase regional clinical trials, ensuring adherence to GCP, SOPs, and FDA/ICH guidelines while collaborating with cross-functional stakeholders to deliver high-quality data within defined timelines and budgets.

Responsibilities:

• 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