Note: The job is a remote job and is open to candidates in USA. Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. The Clinical Project Manager or Sr Clinical Project Manager will oversee global phase I – III oncology clinical trials, ensuring adherence to processes, timelines, and quality standards while interfacing with sponsors and cross-functional teams.
Responsibilities
- Drive the successful execution and proactive management of clinical projects. Serve as the subject matter expert for assigned protocols and provide guidance to cross-functional study teams
- Monitor study enrollment, retention, and metrics to identify trends and act on deviations. Develop and implement strategic solutions for recruitment and retention challenges. Ensure accurate study information is reflected in status reports and clinical trial platforms
- Proactively identify and communicate operational risks, aligning with the study team on mitigation strategies. Oversee the development and adherence to study-specific oversight and Corrective and Preventive Action (CAPA) plans
- Manage the Trial Master File (TMF) for Clinical Operations documentation and ensure inspection readiness. Collaborate with Quality Assurance for internal and external audits
- Proactively manage study-specific timelines and budgets. Review and approve invoices and timesheets. Identify and initiate Change Order (CO) activities as required to maintain project scope
- Lead and manage the day-to-day activities of the study team, including leading team meetings and conducting study-specific training
Skills
- BS. required– preferably in a life science field or equivalent (includes RN degree)
- Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research, with a track record in successfully managing clinical trial sites
- Prior project management experience required
- High level of proficiency with Excel and MS Office; ability to master various electronic platforms for data entry and clinical trial management
- Must be fluent in English (verbal and written)
- Well-developed critical thinking and analytical skills, with the ability to anticipate problems relating to projects and to develop and implement solutions
- Able to seek out multiple and diverse perspectives; open to continuously refining your approach based on feedback and new information
- Knowledgeable of the initiation, conduct, and completion of clinical trials, study endpoints, and clinical databases
- Well-developed and effective written and verbal communication skills, including report writing, preparing, and delivering presentations, and various correspondence and meeting platforms
- Effective knowledge of the drug development process
- Ability to travel occasionally up to 30% when required, domestic and/or global
- Valid Driver's License an advantage
- MS. or PhD. preferred
- Experience with oncology clinical trials and/or cancer therapies is highly preferred (required for senior level project managers)
- Prior involvement with CAR-T or other gene/cell therapies is highly preferred
- Prior experience in a CRO/pharmaceutical environment preferred (required for senior level project managers)
- Basic knowledge of one (or more) European language an advantage
Benefits
- Medical, dental and vision coverage
- Life insurance
- Disability insurance (STD/LTD)
- Company matched 401(k)
- Very competitive tuition reimbursement
- Generous vacation/sick plans
- Flexible work schedules
- Employee discounts
- Other company provided benefits
Company Overview