Clinical Trial Manager
South San Francisco, CA 94080 US
In this role the Clinical Trial Manager supports the clinical operations team with oversight and execution of assigned phase 1/2 clinical trials in collaboration with the assigned CRO. Ability to handle most aspects of site selection, site initiation, and day-to-day site activities with general supervision and/or instruction. Adheres to regulatory documents, good clinical practice and ensures compliance throughout study conduct.
- Working closely with the Clinical Operations team and CRO, providing support as needed for efficient management of sites/study
- Manage assigned aspects of a clinical study to ensure study is completed on time, within budget, and in compliance with FDA regulations and ICH/GCP guidelines
- Support site selection process
- Ensure all study plans are created/approved
- Ensure study questions are addressed on timely basis, including enrollment questions and other site issues that arise
- Review CRO site monitoring visit reports and ensure issues being properly tracked and managed to resolution
- Monitor study enrollment performance against goals and ensure ongoing application of strategies for boosting enrollment/site engagement
- Collaborate with vendors as appropriate to plan and ensure timely receipt of deliverables
- Participate in the design and development of clinical trial protocols and case report forms
- Oversee and/or develop of study-specific documents, e.g., study guides, tools, manuals, and informed consents
- Contribute to the clinical section of the study protocol and assist in document reviews
- Participate in the development of Clinical Trial Agreements with appropriate Company business associate and develop study budgets for sites
- Communicate and closely coordinate with cross-functional team members (eg, lead study management team meeting)
- Support Team efforts to ensure eTMF inspection readiness: ensure study documents filed in eTMF on timely basis and respond to eTMF-related questions
- Conduct/coordinate internal data review cycles as required
- Provide training and guidance on addressing issues of protocol compliance, safety, data and administrative issues with investigational sites and/or regional/CRO monitors as applicable
- Some local travel may be required
Skills, Education and Experience Required
- B.A./ B.S. degree required in the science/health care field, nursing degree, or equivalent related experience.
- Must have at least 4 years of clinical research monitoring and/or 6-10 years applicable experience in clinical operations in Oncology, and/ or other related cell therapy.
- Strong knowledge of clinical research process (FDA regulations and ICH guidelines), including working knowledge of all functional areas of clinical trials and medical terminology
- Requires strong organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Proven skills in monitoring multiple sites from startup through closeout
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Ability to work independently on projects, without supervision from conception to completion, and must be able to work under pressure at times to handle a variety of activities and confidential matters with discretion.
- Systems experience - eTMF, Medidata Rave EDC
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