Theradex OncologyRemote
Clinical Project Manager/ Sr Project Manager
United States of America
Full Time
9 hours ago
$105,000 - $165,000 USD
No H1B
Key skills
Clinical Project ManagementOncology Clinical TrialsClinical Trial ManagementICH/GCP ComplianceRisk ManagementCorrective and Preventive Action (CAPA)Trial Master File (TMF) ManagementBudget ManagementMicrosoft ExcelMicrosoft OfficeCAR-T TherapyGene/Cell TherapyDrug Development ProcessProject Management
About this role
Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. They are seeking a Clinical Project Manager or Sr Clinical Project Manager to oversee global phase I – III oncology clinical trials, ensuring processes, timelines, and quality standards are met.
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
Requirements:
- 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)
- Ability to travel occasionally up to 30% when required, domestic and/or global
- 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)
- Valid Driver's License an advantage
- Basic knowledge of one (or more) European language an advantage