Senior Clinical Data Management Specialist
2 weeks ago
We are seeking a highly skilled Senior Clinical Data Management Specialist to join our team at Lifelancer.
Job SummaryThe ideal candidate will have extensive experience in clinical data management, with a strong understanding of cross-functional activities and excellent problem-solving skills.
Responsibilities- Provide high-level expertise in data management to support clinical studies.
- Lead data transfers with CROs and third-party data sources, SAE/AE reconciliation, and MedDRA/WHO-DD coding.
- Support the transfer, locking, and archiving of study databases.
- Oversee small programs with limited numbers of studies.
- Accountable for providing comprehensive program-level oversight of SDMs to ensure consistency and compliance of program-level standards.
- Bachelor's degree in Mathematics, Science, or a related field.
- A minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries.
- Certified Clinical Data Manager (CCDM).
- Demonstrated broad knowledge of all applicable regulations, including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collections.
- Salary range: $110,900.00 - $181,100.00 annually.
- Inclusive and diverse company culture.
- Comprehensive benefits package.
Lifelancer is an equal opportunity employer and welcomes applications from qualified candidates without regard to race, color, religion, sex, nationality, or any other protected characteristic.
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