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Sr Manager – Clinical Data Management
| Company | Corcept Therapeutics |
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| Location | San Carlos, CA, USA |
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| Salary | $144800 – $212900 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Relational database experience, SAS, and clinical data management systems
- Knowledge of CDISC/SDTM
- Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio)
- Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau, RShiny)
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
- Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical development
Responsibilities
- Provides input into the design of data flow across EDC and non-EDC data sources across vendor network
- Manages data management service providers to ensure the quality of deliverables and that timelines are met
- Develops and contributes to the design of processes enabling near-real-time data access for Corcept clinical trials
- Ensure data quality of clinical database through the implementation of CDISC compliance
- Reviews and critically assesses data query resolution metrics and suggests process improvement
- Reviews study protocols to ensure that data collection and CRF design meet study objectives
- Manages and oversees SAE and external vendor reconciliation between clinical and applicable databases
- Review clinical data for completeness, accuracy, and consistency in accordance with the investigational plan
- Provide subject matter expertise to project team members during all phases of the project life cycle
- Provides accurate and timely clinical data to internal and external customers upon request
- Manage development, test, and maintain data management systems
- Support the development and periodic review of Data Management specific SOPs, WIs, and templates
- Provide subject matter expertise prior, during, and post internal and external audits and inspections
- Maintain compliance with company and study-specific learning requirements
Preferred Qualifications
- Bachelor’s or higher in science, math, or computer science
- 5+ years’ experience in data management in the clinical trial industry (med device, pharma, or biotech)
- Experience in IT-related field
- Experience with Oncology or rare disease clinical trials and CDISC therapeutic area standards
- Experience with management of data flow and curation of biomarker data
- Experience managing Data Management CROs and vendors
