Associate Director, Clinical Data Management

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.

 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

Preferred Skills, Qualifications or Technical Proficiencies:

• 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

Preferred Education and Experience:

• 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)
• Minimum of 3 years experience in preparing, executing, and finalizing Medical Coding (MedDRA and WHODrug) within the Medidata Rave Coder system
• Strong knowledge of the MedDRA and WHODrug dictionaries along with their uprevisions
• 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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $229,300 – $269,800; 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.