Principal Specialist, Clinical Data Mgmt
Neurocrine Biosciences · Home, MA
BiometricsFull-time$131k–$179kCompany career page
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Role summary
Neurocrine Biosciences seeks a Principal Specialist in Clinical Data Management to lead data management activities for clinical studies, overseeing both in-house and outsourced trials. The role involves designing data systems, ensuring regulatory compliance, and collaborating across departments to maintain high-quality clinical data.
What they're looking for
- Bachelor's degree in computer science or related field plus 8+ years pharmaceutical industry experience
- Master's degree in computer science or related field plus 6+ years pharmaceutical experience
- PhD in computer science or related field plus 4+ years pharmaceutical experience
- 3+ years experience in supervisory or lead capacity
- Thorough understanding of drug development processes
- Experience with electronic case report forms and clinical database design
- Knowledge of regulatory standards and data quality management
What you'll be doing
- Lead data management activities for assigned clinical studies and programs, including First-In-Human trials
- Design electronic case report forms, database specifications, and coordinate user acceptance testing
- Perform data quality checks, discrepancy reviews, and collaborate on interim analyses and database locks
- Develop and implement data management policies, SOPs, and training for internal and external teams
- Oversee vendor selection for data management software and monitor outsourced CRO performance
Privacy & handoff
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