​​Manager, Clinical Data Scientist, Clinical Data Sciences

WHY PATIENTS NEED YOU

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

POSITION SUMMARY

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, You are responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. You deliver 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. You design, develop, and maintain 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.  

KEY 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 Risk-Based Monitoring (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. 

MINIMUM QUALIFICATIONS

• 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 

• 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. 

PREFERRED QUALIIFICATIONS

• Master’s degree preferred. 

PHYSICAL/MENTAL REQUIREMENTS 

• Primarily an office-based position involving sitting, walking to meetings, making pre