Clinical Project Manager/ Sr Project Manager

Theradex Oncology is a full-service oncology CRO. The Clinical Project Manager or Senior Clinical Project Manager oversees global Phase I–III oncology trials from feasibility and startup through closeout, ensuring timelines, budgets, quality, and ICH/GCP adherence. The role coordinates sponsors, vendors, study teams, and investigative sites while managing trial risks and execution.

Responsibilities:

• Clinical Project Leadership: 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
• Study Oversight: 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
• Risk and Quality Management: 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
• Compliance and Audits: Manage the Trial Master File (TMF) for Clinical Operations documentation and ensure inspection readiness. Collaborate with Quality Assurance for internal and external audits
• Budget and Timelines: 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
• Team Management: Lead and manage the day-to-day activities of the study team, including leading team meetings and conducting study-specific training

Requirements:

• BS required
• Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research
• 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
• (required for senior level project managers)
• Prior experience in a CRO/pharmaceutical environment (required for senior level project managers)
• 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
• preferably in a life science field or related filed (includes RN degree)
• MS or PhD preferred
• (minimum 5 years for Sr level)
• Experience with oncology clinical trials and/or cancer therapies is highly preferred
• Prior involvement with CAR-T or other gene/cell therapies is highly preferred
• Prior experience in a CRO/pharmaceutical environment preferred
• Valid Driver's License an advantage
• Basic knowledge of one (or more) European language an advantage