Pfizer
1 month ago
Clinical Data Scientist Manager Clinical Data and Information Sciences
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Company information
- Company
- Pfizer
- Location
- India, Tamil Nadu, Chennai India
- Posted
- 1 month ago
Job description
As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development Operations (CD&O) organization, the Clinical Data Scientist is responsible for representing CDIS at the study team level. The Clinical Data Scientist is accountable for the coordination of all CDIS deliverables associated with a clinical trial, as well as adherence to data standards and the quality of the study data sets. The Clinical Data Scientist provides leadership, direction, and oversight to Data Managers working on the clinical trial and is accountable for the trial's inspection readiness. Serve as Clinical Data Scientist for one or more clinical trials, assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third-party study data due diligence. As a member of the Core Study Team, drive operational excellence in collaboration with cross-functional partners through the application of CDIS best practices at the study level. Serve as technical resource on how to best collect, process, consume, and report clinical trial data. They are accountable for the quality and timeliness of all CDIS deliverables in support of the clinical trial. They partner with Research Business Units, external data service providers, and internal CDIS staff to deliver high-quality data management for all studies as assigned. Proactively drives quality and efficiency to meet study asset timelines and milestones, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross-functional study team. Ensure work carried out on behalf of CDIS is in accordance with applicable SOPs and work practices, accountable for assuring adherence to regulations, standards, GCDMPs, ALCOA principles by the team they are coordinating. Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. Work with Asset Leads to establish strategy, timelines, and adequate resourcing of the study. Provide leadership, direction, and oversight to the CDIS resources working on the clinical trial(s). Work Location Assignment: On Premise. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI use guidelines available on Pfizer Careers. Medical.
Required skills
- regulations
- quality
- efficiency
- operational excellence
- strategy
- standards
- best practices
- data quality
- timelines
- due diligence
- sops
- tmf
- equal opportunity employer
- resourcing
- milestones
- data standards
- timeliness
- data sets
- clinical trial
- data managers
- clinical development operations
- inspection readiness
- on premise
- cross-functional partners
- process data
- scientific excellence
- technical resource
- strategic imperatives
- trial master file
- ai use guidelines
- work practices
- report data
- clinical data scientist
- clinical data and information sciences
- cdis
- cd&o
- study team
- data acquisition standards
- data management plan
- quality risk indicators
- third-party study data
- core study team
- collect data
- consume data
- research business units
- external data service providers
- internal cdis staff
- high-quality data management
- study asset timelines
- gcdmps
- alcoa principles
- contemporaneous filing
- asset leads
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