Responsibilities
- Leads one or more complex clinical studies independently, with limited supervision.
- Serves as the primary data management representative in cross-functional study teams.
- Provides guidance and professional development support to junior data management staff.
- Oversees and tracks data management tasks performed by external vendors and contract research organizations, fostering strong working relationships.
- Evaluates clinical protocols to ensure proper structure and scope for data collection.
- Conducts in-depth analysis of electronic case report form (eCRF) data needs and develops forms when necessary.
- Collaborates with clinical research associates, programmers, study leads, and biostatisticians on eCRF design, annotation, and completion instructions.
- Directs the creation of data validation rules and specifications for data listings.
- Coordinates the setup and validation of electronic data capture (EDC) systems in alignment with internal standards.
- Troubleshoots and resolves issues related to EDC platform functionality with internal and external stakeholders.
- Authors or oversees the development of comprehensive data management plans for clinical trials.
- Reviews key study documentation including statistical analysis plans and vendor deliverables to ensure data consistency.
- Delivers training on EDC platforms and eCRF completion procedures for internal teams, external partners, and at investigator meetings.
- Conducts data reconciliation between external source documents and the clinical database.
- Manages reconciliation of serious adverse event data in compliance with standard operating procedures.
- Leads database enhancements and migration efforts, including user acceptance testing.
- Executes database lock and freeze procedures following company protocols.
- Upholds organizational values, compliance standards, and ethical business practices.
- Completes additional tasks as required by project or leadership needs.
Team
multi-disciplinary team
