Clinical Trial Manager
4 hours ago
Parexel is seeking a skilled Clinical Trial Manager to join our team.
About the RoleThis is a critical position that requires strong problem-solving skills, ability to work independently, and excellent communication skills. The successful candidate will be responsible for ensuring timely and accurate completion of project goals and update of applicable trial management systems.
Responsibilities- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Ensure that assigned sites are audit and inspection ready
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Parexel is a leading global biopharmaceutical services company. We provide full-service contract research organization (CRO) solutions to help clients succeed in drug and device development.
Salary Range$85,000 - $115,000 per year, depending on location and experience.
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