As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Data Manager is responsible for timely and high quality data review and query management of clinical data supporting the Pfizer portfolio. The Data Manager develops and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
Serve as Data Manager for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.
- In collaboration with the Clinical Data Scientist, ensure operational excellence across all DMM deliverables.
- Ensure work carried out in accordance with applicable SOPs and working practices.
- 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.
- 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.
- Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP
- Demonstrated knowledge of data management processes and principles in area of responsibility.
- Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
- Demonstrates strong verbal and written communication skills including ability to communicate remotely
- Minimum 3 years Data Management experience required
- Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
- 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
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Bachelor's degree minimum requirement or at least 12 years of relevant data management pharma industry experience.
- Must be in office at least 3 days per week.