Senior Manager, Clinical Data Management

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.

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 Skills, Qualifications, or Technical Proficiencies:

• 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

Preferred Education and Experience:

• 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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $170,550 – $200,700; 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.