Sr. Clinical Data Manager
Job in
Kennesaw, Cobb County, Georgia, 30156, USA
Listed on 2026-09-18
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-18
Job specializations:
-
IT/Tech
Information Security & Data Protection, Data Analyst, Data Scientist, Data Science Manager
Job Description & How to Apply Below
Role:
Senior Clinical Data Manager overseeing data management for medical device clinical trials, ensuring data integrity from study start-up to database lock.
Responsibilities:
- lead end-to-end data activities, develop and maintain study documents, oversee database build, testing, and validation
- collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory, QA, and CROs
- ensure compliance with GCP, FDA, MDR/IVDR standards
- support audits and regulatory inspections
- mentor junior staff and contribute to process improvements
- Bachelor’s or Master’s in Life Sciences, Data Science, or related field
- 7+ years in clinical data management with 2+ years in a senior/lead role
- experience with medical device or combination product trials (IDE, PMA, 510(k))
- strong EDC, CDASH, SDTM, and CDISC knowledge
- understanding of regulatory standards (FDA, EMA, ISO 14155, GDPR)
- experience in FDA-regulated/ISO-certified environments
- proficiency in data visualization and analytics tools (Python, R)
Work Setup: not specified.
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