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Clinical Trial Manager

South San Francisco, CA 94080

Posted: 01/26/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 539042 Is job remote?: Yes Country: United States

Job Description


Job Scope

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.

Job Duties
  • 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
Hourly Pay Rate of 80-100 per hour 
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