The Clinical Data Scientist leads data management activities for clinical trials, ensuring quality data collection and compliance with standards. They coordinate with internal and external teams for efficient data management and ensure operational excellence in clinical data processes.
ROLE SUMMARY
As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Clinical Data Scientist (CDS) is responsible for timely and high-quality data management deliverables supporting the Pfizer portfolio. The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.
ROLE RESPONSIBILITIES
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Clinical Data Scientist (CDS) is responsible for timely and high-quality data management deliverables supporting the Pfizer portfolio. The CDS delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine. The CDS designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.
ROLE RESPONSIBILITIES
- Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
- Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting
- Partners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned.
- Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
- Ensure work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.
- Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
- Ensure the required study specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
- Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Top Skills
Clinical Data Standards
Data Management
Data Review Tools
Electronic Data Capture (Edc)
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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