Senior Associate, Data Manager, Clinical Data Sciences
- Pfizer
- 10 - 12 years
- Chennai
- 2 months ago
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Job Description
As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development Operations (CDO) 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 executes on key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data.
- Serve as Data Manager with minimal supervision for one or more clinical trials assuming responsibility for CDIS 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 CDIS deliverables.
- Ensure work carried out in accordance with applicable SOPs and working practices.
- Ensure the required study-specific CDIS 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 CDIS 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.
Work Location Assignment: On Premise
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Data Science & AnalyticsRole Category: Business Intelligence & AnalyticsRole: Analytics / BI ManagerEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Chennai+ View Contact
Keyskills: Operational excellence Data management EDC Database design Query management Clinical trials clinical development Data collection Downstream clinical data
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