Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

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

Corcept Therapeutics is hiring for this role on CareerPlace.

Apply on the company website through Corcept Therapeutics.

Imported from employer careers page. Source ref: 6b9e1da71b82.