Associate Director, Clinical Data Management
- Employer
- Corcept Therapeutics
- Location
- Menlo Park, California
- Start date
- Dec 1, 2021
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- Discipline
- Clinical, Clinical Data, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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Job Description
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 Senior Director of Biometrics to select and maintain preferred vendor network for Biometrics
- 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 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.
- B.Sc/B.A or higher in science, math or computer science
- 12+ 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 a plus
- Experience with management of data flow and curation of biomarker data a plus
- Experience managing Data Management CROs
- Direct report management and oversight a plus
- 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, Tablo, 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
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