Clinical Trial Specialist / Associate Clinical Trial Manager
United KingdomFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- At least 3 years of experience (4yrs preferred) in clinical studies
Requirements
- M.S/M.A/Ph.D or B.A/B.S/nursing degree.
- At least 3 years of experience (4yrs preferred) in clinical studies.
- Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
- Understanding of study phases and clinical development.
- Ability to work independently and in a team environment.
- Advanced knowledge of Word, Excel, and PowerPoint.
- Working knowledge of electronic systems including Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint).
- Knowledge of database management principles.
Responsibilities
- Support Phase 1, 2, 3 and 4 clinical studies with guidance.
- Support activities related to study/site feasibility, start-up, maintenance, and close-out.
- Manage study and site essential document review, collection, tracking, etc.
- Support the Study Lead in preparing and maintaining study documents and manuals.
- Oversee Trial Master File (TMF) to ensure documents are filed in accordance with SOPs, GCP and regulations.
- Organize study related meetings including agenda/minute taking and maintenance of decision logs.
- Perform site monitoring / co-monitoring visits.
- Assist with vendor oversight and management.
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