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.
