Associate Director, Clinical Quality Assurance

Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity. 

Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases. Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since its founding in 1998.

The Associate Director, CDM will Ensure 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 Senior Director of Biometrics to select and maintain preferred vendor network for Biometrics
• 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 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 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, 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, Tablo, 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

• B.Sc/B.A or higher in science, math or computer science
• Master’s Degree in health care or life sciences preferred
• 12+ 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)
• Experience in IT-related field a plus
• Experience with Endocrinology clinical trials and CDISC therapeutic area standards a plus
• Experience with management of data flow and curation of biomarker data a plus
• Experience managing Data Management CROs
• Direct report management and oversight a plus

Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol. Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases.

We have gratitude and appreciation for the commitments and convictions of our employees who share a sense of responsibility to find better ways to improve patients’ lives.