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 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.
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
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) 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
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 $170,550 – $200,700; 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 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.
Originally posted by Corcept Therapeutics. View original posting
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