Participates in preparing function for submission readiness.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Acts as a process expert for operational and oversight models.
- May prepare metrics to support the function’s KPIs.
- Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables
- Champions and adopts technology improvements and tools for use in clinical data management processes.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirement. Performs other duties as assigned.
Key Accountabilities-
Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience preferred.
- Robust knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Special Skills/Abilities
- Advanced knowledge of office software (Microsoft Office).
- Experience with budget planning & management.
- Strong knowledge of relational databases and experience using multiple clinical data management systems.
- Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
- Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
- Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.
- Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.