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. To learn more, visit www.corcept.com.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.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. 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. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.