The Clinical Data Management Specialist II ensures optimized data collection, flow, and access across EDC and non-EDC data sources. Responsible for accuracy, completeness, and CDISC compliance of Corcept clinical data.
Responsibilities:- Provides input into the design of data flow across EDC and non-EDC data sources across vendor network
- 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
- Provides accurate and timely clinical data to internal and external customers upon request
- Test, and maintain data management systems
- Support the development and periodic review of Data Management specific SOPs, WIs, and templates
- Maintain compliance with company and study-specific learning requirements
Preferred Skills, Qualifications, or Technical Proficiencies: - Relational database experience, SAS, and/or 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
Preferred Education and Experience: - Bachelor's or higher in science, math, or computer science
- 2+ years' experience in clinical research and/or 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
The pay range that the Company reasonably expects to pay for this headquarters-based position is $88,200 - $100,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
