Job Description

ROLE DETAILS
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ROLE SUMMARY
Summarize the primary purpose & key accountabilities of the role, including geographical scope (i.e. Global vs. Country/Region).
Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
ROLE SUMMARY
As part of the Data Monitoring and Management (DMM) 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.
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
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, bothCRF 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
Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
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 (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
+ 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 prefer
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