Other responsibilities include contribution to the definition of defined company data standards and conventions. Functioning as an advisor for Clinical Data Management activities to all project teams. Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. May contribute to department and other project budget planning.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Company policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.
First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
- Be responsible for the role which includes the management and maintenance of clinical data and interfacing with clinical teams. Provides leadership and content expertise for Clinical Data Management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities. Member of the Protocol Review Team, CRF Review Team, Medical Safety Monitoring Plan Reviewer, member of the Clinical Study Report Review Team, and may perform peer review of Clinical Data Management deliverables as a Peer Data Management Lead. In addition, the incumbent is the key contact for Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non-Translational Sciences (NTS).
- Be responsible for the role which includes participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable Company processes and procedures. Involvement in assessment/re-assessment of vendor capabilities, as necessary. In addition, the incumbent is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO).
- Be responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Data Management tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Data Management and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Data Management staff. Supports Corrective and Preventative (CAPA) Action initiatives as needed. In addition, the incumbent is the key contact for Process, Training, and Continuous Improvement (PTCI) and Global Research & Development Quality (GRDQ).
- Bachelor’s Degree with a proven level of relevant work experience in Clinical Research, Computer Science, Project Management or related field.
- Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).
- Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.
- Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.).