Sr Manager, Clinical Data Management

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Sr Manager, 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. This is a hybrid position typically requiring on-site presence 3 days per week.

 Responsibilities:

• Provides 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 the 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 and external vendor reconciliation between clinical and applicable databases
• 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 the project life cycle
• Provides accurate and timely clinical data to internal and external customers upon request
• Manage development, test, and maintain data management systems
• Support 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 and Technical Proficiencies: 

• Relational database experience, SAS, and clinical data management systems
• Knowledge of CDISC/SDTM. Hands-on experience preferred
• Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio)
• Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau, RShiny) is 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:

• Bachelor’s or higher in science, math, or computer science
• 5+ years’ experience in data management in the clinical trial industry (med device, pharma, or biotech)
• Experience in IT-related field
• Experience with Oncology or rare disease clinical trials and CDISC therapeutic area standards
• Experience with management of data flow and curation of biomarker data
• Experience managing Data Management CROs and vendors

 The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; 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

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