Senior Manager, Clinical Data Management
The Senior Manager, CDM, is responsible for all data processes related to assigned studies, overseeing data collection workflows across the EDC database and non-EDC data sources. Ensures the quality and integrity of all clinical data via CRF and edit check specifications, Data Management plans, data systems UAT, listing generations, as well as review of clinical data for completeness, accuracy, and compliance.
Essential Duties & Tasks
- Day-to-day management of vendors involved in data production or manipulation, to ensure quality of deliverables and that set timelines are met.
- Develop and/or review study plans including but not limited to Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines.
- Review of study protocols to ensure that data collection and CRF design meet study objectives.
- Develop and/or review specifications for database build, edit checks, external system integration, or for other systems or processes related to data.
- Ensure data quality of clinical database through implementation of CDISC compliance.
- Review clinical data for completeness, accuracy and consistency in accordance with study plans.
- Input into the design of data flow across EDC and non-EDC data sources and across vendors.
- Develop and contribute to design of processes enabling near-real time data access for Corcept clinical trials.
- Review and critically assess data management metrics and suggests improvements.
- Manages and oversees SAE reconciliation between clinical and pharmacovigilance database.
- Manages and oversees external data reconciliation with the clinical database.
- Provide subject matter expertise to study team members during all phases of the project life cycle.
- Provides accurate and timely clinical data to internal and external consumers upon request.
- Manage development and periodic review of Data Management specific SOPs, WIs, and templates
- Provide subject matter expertise prior, during, and after internal and external audits and inspections.
- Maintain compliance with company and study-specific learning requirements.
Preferred Education & Experience
- Sc./B.A. or higher in science, Biology, mathematics or computer science
- 5+ year experience in clinical trial industry (med device, pharma or biotech)
- 3+ year experience in data management in clinical trial industry (med device, pharma or biotech)
- Experience managing Data Management CROs
- Deep Experience in reviewing clinical data
- Hands-on deep experience working with EDC systems (e.g. Rave, Medrio, Inform)
- Practical experience building studies using CDISC/CDASH standard
- Experience with Endocrinology and Metabolic diseases a plus
- Experience with a programming language a plus
- Experience with management of data flow and curation of biomarker data a plus
Preferred Skills, Qualifications, or Technical Proficiencies
- In-depth understanding of clinical and Data Management regulations and guidelines: ICH, GCDMP, 21CFR Part 11
- CCDM certification preferred
- Deep expertise in Excel and office tools
- Knowledge of Project Management Principle. PMP a plus
- Functional knowledge of CDISC/SDTM/SDTMIG standards
- Practical knowledge of MedDRA, WHODrug and/or another controlled Thesaurus
- Relational database understanding and SQL knowledge
- Familiarity with Data Visualization Tools (e.g. Spotfire, Tableau, RShiny, Dash)
- Understanding of data manipulation, for example using SAS, R, or Python/Pandas