Manager, Clinical Data Scientist, Clinical Data

3 weeks ago

Kirkland, Canada Pfizer Full time

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 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.

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 preferred

PHYSICAL/MENTAL REQUIREMENTS

Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel approximately 5 to 10%

Pfizer encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Pfizer will accommodate the needs of applicants with disabilities throughout all stages of the selection process. Should accommodation during the recruitment process be required, please advise your Talent Acquisition representative.

- Medical

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