Associate Director, Clinical Data Management
Corcept Therapeutics
Corcept Therapeutics seeks an Associate Director of Clinical Data Management to oversee data collection, integrity, and compliance across clinical trial systems. The role involves managing vendor relationships, ensuring CDISC standards, and optimizing data flow from multiple sources to support ongoing clinical programs.
Responsibilities
- Collaborate with Director to select and maintain clinical data management vendor network
- Manage data quality and CDISC compliance across EDC and non-EDC clinical databases
- Design and oversee processes enabling near real-time data access for clinical trials
- Review protocols and CRF designs to ensure alignment with study objectives
- Manage SAE reconciliation between clinical and pharmacovigilance systems
Requirements
- Master's degree in healthcare or life sciences preferred
- SQL, SAS, and relational database experience
- CDISC/SDTM knowledge with hands-on implementation experience
- Proficiency with mainstream EDC platforms like Rave, Medrio, or Inform
- Understanding of MedDRA, WHODrug, and medical coding systems
- Familiarity with data visualization tools such as Spotfire or Tableau
- Knowledge of ICH guidelines, GCDMP, and 21 CFR Part 11 regulations
$186k - $233k
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