Clinical Trial Manager – FSP
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Job Description
Clinical Trial Manager managing external vendors and overseeing clinical trial execution for Parexel. Ensuring adherence to GCPs and leading study material design and documentation.
Responsibilities:
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
- Provide guidance, direction, and management to CRAs
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
- Review Informed Consent Forms, CRFs, and study related materials
- Plan and participate in investigator meetings
- Ensure trial master file is current and maintained
Requirements:
- Degree in the life sciences field preferred
- Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
- Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
- Experience of data management and query resolution in clinical trials
- Overall knowledge of site management and monitoring procedures
Benefits:
- Health insurance
- Paid time off
- Flexible working hours
- Professional development opportunities
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