Job Description
Job Description
Responsibilities:
- Provides 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 clinical trials
- Ensure data quality of clinical database through the 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 and external vendor reconciliation between clinical and applicable databases.
- 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 the project life cycle.
- Provides accurate and timely clinical data to internal and external customers upon request.
- Manage development, test, and maintain data management systems
- Support the 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
Requirements:
- Bachelor's or higher in science, math, or computer science.
- 5+ years' experience in data management in the clinical trial industry (med device, pharma, or biotech).
- Experience with Oncology or rare disease clinical trials and CDISC therapeutic area standards.
- Experience with management of data flow and curation of biomarker data.
- Experience managing Data Management CROs and vendors.
- Relational database experience, SAS, and clinical data management systems
- Knowledge of CDISC/SDTM. Hands-on experience preferred
- Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio)
- Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau, RShiny) is 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.