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Clinical Data Manager
2 months ago
Lifelancer is seeking a highly skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for ensuring the quality and integrity of clinical data in support of regulatory submissions and product approvals.
Key Responsibilities- Act as primary liaison between Lifelancer and CRO for Data Management, providing support and oversight for the CRO Data Management team.
- Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs, ensuring all documents follow study design and regulatory requirements.
- Review clinical study protocols and provide comments if any, ensuring compliance with regulatory guidelines such as GCP, 21 CFR Part 11, etc.
- Provide leadership and support for cross-functional tasks, processes, and training, ensuring effective data management practices and technologies related to clinical trials.
- Monitor data cleanup activities performed by CRO, ensuring data quality and integrity.
- Master's degree or higher in science or related discipline.
- Minimum of 5 years of CDM experience in pharmaceutical/biotech industry.
- Practical experience with successful submissions and product approvals from global regulatory authorities across multiple therapeutic areas.
- Thorough and broad knowledge of data management processes, including EDC and IWRS experience.
- Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11, etc.
- Solid understanding of clinical research methods, CDISC principles, best data management practices and technologies related to clinical trials.
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