Manager, Clinical Data Scientist, Clinical Data Sciences

Pfizer; Chennai; In loco; INR 900.000 - 1.500.000; Tempo pieno

Descrizione del lavoro

Pfizer in Chennai, India, is seeking a Clinical Data Scientist within the CDIS group of CD&O to coordinate all CDIS deliverables for clinical trials and ensure data standards and study data quality. You will lead Data Managers and provide oversight for inspection readiness.

As a Core Study Team member, you will drive operational excellence, advise on data collection, processing and reporting, and collaborate with internal and external partners to deliver timely, compliant data management across

Mansioni

• Lead CDIS activities for one or more trials, including data standards, DMP, risk indicators, and third party data due diligence.
• Drive operational excellence with cross-functional partners; advise on data collection, processing, and reporting.
• Ensure quality and timeliness of CDIS deliverables; partner with units and external providers for data management.
• Improve quality and efficiency to meet study timelines with cross-functional teams.
• Ensure CDIS work complies with SOPs, regulations, GCDMPs, and ALCOA by coordinating the team.
• Ensure TMF documents are high quality and filed in a timely manner.
• Collaborate with Asset Leads to set strategy, timelines and resources.
• Provide leadership and oversight to CDIS resources on trials.

Descrizione del lavoro

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 milestones, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team.
• Ensure work carried out by/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

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Medical

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