Associate Director, Clinical Data Management

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.

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
• Ensures 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
• Reviews clinical data for completeness, accuracy, and consistency in accordance with the investigational plan
• Provides 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
• Manages development, test, and maintenance of data management systems
• Manages development and periodic review of Data Management specific SOPs, WIs and templates
• Provides subject matter expertise prior, during, and post internal and external audits and inspections
• Maintains compliance with company and study-specific learning requirements

Requirements

• Bachelor’s or higher in science, math or computer science
• 10+ years experience in clinical trial industry (med device, pharma or biotech)
• 10+ years 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

Skills

• 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

Pay

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.