Associate Director, Clinical Data Management

Corcept Therapeutics • Redwood City, CA

7d • Onsite

About The Position

The Associate Director, 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

• Bachelors or higher in science, math or computer science
• 10+ year experience in clinical trial industry (med device, pharma or biotech)
• 10+ year experience in data management in clinical trial industry (med device, pharma or biotech)
• Applicants must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

• Master’s Degree in health care or life sciences preferred
• Relational database experience, SQL, SAS, and clinical data management systems
• Knowledge and experience with MedDRA, WHODrug and other Thesaurus classification of controlled management systems
• Knowledge of CDISC/SDTM. Hands-on experience preferred
• Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio, Inform)
• Familiarity with Data Visualization Tools for quick customized data access (e.g Spotfire, 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
• Experience in IT-related field a plus
• Experience with Endocrinology clinical trials and CDISC therapeutic area standards
• Experience with management of data flow and curation of biomarker data a plus
• Experience managing Data Management CROs
• Direct report management and oversight

Responsibilities

• Works in cooperation with Director of Clinical Data Management to select and maintain preferred vendor network for data management activities
• Reviews, proposes and obtains bids for tools enabling real-time data visualization, interrogation, and reporting
• Manages strategic 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 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 reconciliation between clinical and pharmacovigilance database
• 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 project life cycle
• Provides accurate and timely clinical data to internal and external customers upon request
• Manage development, test, and maintain data management systems
• Manage 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager