Clinical Project Manager or Sr Clinical Project Manager based on experience. Location: USA Remote Theradex Project Managers oversee global phase I - III oncology clinical trials from feasibility and startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met. As a key point of contact you'll interface directly with sponsors, vendors, cross-functional team members and investigative sites. You'll identify and evaluate risks, interpret data on complex issues and implement solutions to ensure successful completion of oncology trials.
Key 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.
What You NeedEducation and Experience: - BS required - preferably in a life science field or related filed (includes RN degree)
MS or PhD preferred - Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research (minimum 5 years for Sr level), 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
- 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 (required for senior level project managers)
- Must be fluent in English (verbal and written)
Skills and Competencies- 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
- Thorough knowledge of current European and North American regulations and any applicable guidelines
- Highly effective ability to set and meet personal short- and long-term goals
Additional Requirements- Ability to travel up to 30% when required, domestic and/or global
- Valid Driver's License an advantage
- Basic knowledge of one (or more) European language an advantage
What We OfferAt Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes 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 and other company provided benefits. The annual base salary for this position ranges from $105,000-$165,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for company provided sponsorship or relocation.
