As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Senior Data Manager is responsible for timely and high-quality data review and query management of clinical data supporting the Pfizer portfolio. The Senior Data Manager develops and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
- Ensure work carried out in accordance with applicable SOPs and working practices.
- Ensure operational excellence in collaboration with CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
- In collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables.
- Be responsible to achieve the study DM milestone on time with good quality.
- Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
- Coach junior Data Managers in the study and perform peer review of study DM’s deliverables for quality control.
Qualification & Experience:
- Proficient experience using commercial clinical data management systems and/or EDC products (e.g., Inform preferred)
- Experience using data visualization tools (e.g. Spotfire, J-Review) preferred
- Familiarity with MedDRA/WHO-Drug
- Minimum 8 years Data Management experience required
- Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements