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)

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.