Senior Manager, Clinical Data Management
About The Position
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. The Sr Manager, Clinical Data Management, ensures optimized data collection, flow, and access across EDC and non-EDC data sources. Responsible for accuracy, completeness, and CDISC compliance of Corcept clinical databases.
Requirements
- Relational database experience, SAS, and clinical data management systems
- Knowledge of CDISC/SDTM. Hands-on experience preferred
- 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) a plus
- 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
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
