1+ months

Manager, Clinical Data Scientist, Clinical Data Sciences, DMM

Pfizer
Hedgesville, WV 25427
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**Role Summary**

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist and Trial Lead (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 CDS may have direct reports.



**Role Responsibilities**

Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all DMM 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 DMM 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 DMM 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 DMM 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.



**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

Strong verbal and written communication skills

Consistent, detail oriented, communicative, dedicated to do a job well done

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 (e.g. Medidata RAVE, Oracle RDC / Inform, etc.)

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

Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Bachelor's degree required. Degree in scientific field preferred. Master's degree preferred.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical
Posted: 2021-03-12 Expires: 2021-05-13
Sponsored by:
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Manager, Clinical Data Scientist, Clinical Data Sciences, DMM

Pfizer
Hedgesville, WV 25427

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