Manager, Clinical Data Scientist, Clinical Data Sciences

$93,500 - $155,900/Yr

Pfizer - Tampa, FL

Full-time - Mid Level

Tampa, FL

Chemical Manufacturing

About the position

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) 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. The Clinical Data Scientist will serve as the Trial Lead for one or more clinical trials, assuming responsibility for all CDS activities including the selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third-party study data due diligence. This role requires proactive engagement with study teams to ensure scientific and operational excellence in support of strategic imperatives. The CDS will also ensure that all work carried out is in accordance with applicable SOPs and working practices, and will participate in quality database design, documentation, testing, and implementation of clinical data collection tools. In this position, the Clinical Data Scientist will ensure operational excellence in collaboration with partners for the application of standards, data acquisition, proactive data review, data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release. This role is critical in ensuring that high-quality data management is delivered for all assigned studies, ultimately contributing to the success of Pfizer's clinical trials and the advancement of patient care.

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
• Partner with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned
• Proactively drive 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
• Participate and ensure 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

Requirements

• Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
• Strong Project and Risk Management skills
• CRO and vendor oversight experience preferred
• Minimum 5 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 (Oracle RDC / Inform preferred)
• Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
• Familiarity with MedDRA/WHO-Drug
• Bachelor's degree required. Degree in scientific field preferred.

Nice-to-haves

• Master's degree preferred.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage
• Participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary
• Eligibility to participate in share-based long term incentive program
• Relocation assistance may be available based on business needs and/or eligibility.