Manager/Senior Manager, Clinical Documentation Management
New
O
OraOphthalmic clinical research
Remote - EU; Remote - USFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in Life Sciences or equivalent work experience.
- 5+ years of experience in clinical operations, clinical documentation, quality, or a related function within pharmaceutical or CRO environments.
- Minimum 2 years of experience with eTMF/record management systems.
- For Senior Manager: 3+ years of people management experience.
- For Manager: Minimum of 1 year of people management, team lead, or supervisory experience.
- Strong understanding of ICH-GCP, TMF Reference Model, and documentation best practices.
- Experience with Veeva Vault eTMF preferred.
- Strong analytical and problem-solving skills with ability to interpret quality trends.
- Clear and consistent writing skills; experience contributing to SOPs or process documents.
- Excellent verbal and written communication skills.
- Ability to travel up to 10%.
Responsibilities
- Manage and develop a portion of the Clinical Documentation (eTMF) team, supporting performance, workload prioritization, and professional growth.
- Reinforce operational excellence and consistency in eTMF execution across assigned studies.
- Ensure eTMF activities align with ICH-GCP, GxP, and applicable local regulatory requirements.
- Contribute to the refinement and implementation of eTMF processes, SOPs, work practices, and templates.
- Monitor eTMF completeness, accuracy, and risk indicators for assigned studies.
- Deliver eTMF-related training to internal teams and provide ongoing guidance.
- Support the implementation, maintenance, and user adoption of document management systems like Veeva Vault or SharePoint.
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