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Clinical Data Manager
2 months ago
Lifelancer is seeking a skilled Clinical Data Manager to support one of the world's top pharmaceutical companies. As a key member of the Clinical Trial Team, you will be responsible for delivering high-quality data management activities from study set-up to close-out, ensuring compliance with GCP and regulatory guidelines.
Main Responsibilities:- Leadership: Provide data management leadership and expertise to the Clinical Trial Team.
- Study Set-Up:
- eCRF set-up and UATs
- Development and review of study plans and documents
- Organize and conduct strategy meetings with the study team
- Interaction with external vendors
- Study Conduct/Closure:
- Manage data validation and queries
- Review data reports and implement corrective actions
- Handle third-party data loading and reconciliation
- Organize and conduct data review and database lock meetings
- eTMF archiving
- Vendor Management: Maintain a good working relationship with external vendors and monitor their performance. Implement mitigation actions as necessary.
- Bachelor's, Master's, or PhD degree in life sciences, mathematics, or a related field
- 1-3 years of Clinical Data Management experience for Junior role, 5-8 years for Manager role, and 8+ years for Senior Manager role
- Knowledge of Clinical Trial Development Processes and ICH-GCP
- Strong communication and interpersonal skills
- Experience with clinical study management tools and systems
- Ability to manage multiple external data systems
- Proficiency in Microsoft Office
- Fluent in English (written and spoken)
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