Pfizer
Biopharmaceutical
Manager,SeniorClinicalDataScientist
Neural analysis suggests this role is
optimal for Senior candidates.
“Manager, Senior Clinical Data Scientist at Pfizer. Skills: Clinical Data Management, Data Integrity, Data Management Deliverables, Information Strategies, Precision Medicine, Data Collection Systems. timely and high-quality data management deliverables. asset level information strategies and services”
What You'll Achieve.
timely and high-quality data management deliverables; optimal use and reuse of internal and external information; advance research, development, and commercialization of the Pfizer portfolio; further precision medicine; ensure the integrity of clinical data; quality study data set release and consistency in asset/submission data; high quality and contemporaneously filed TMF documents; effective reporting of study status and metrics to Management
Industry & Context.
providing solutions
What They're Looking For.
Must Have
Bachelor’s degree, Minimum 7 years Data Management experience, experience in team leadership, Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting, Working knowledge of all phases of clinical trials, ability to assess and determine study requirement from protocol review, Project and Risk Management, Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements, Proficient experience using commercial clinical data management systems and/or EDC products, Experience using relational databases, Proficiency in the use of Microsoft Office Suite of tools
Nice to Have
Degree in scientific field preferred, Master’s degree preferred, CRO and vendor oversight experience preferred, knowledge of MedDRA/WHO-Drug
What You'll Do.
timely and high-quality data management deliverables
asset level information strategies and services
and maintain key data management deliverables
and ensure the integrity of clinical data
data review and query management
quality study data set release and consistency in asset/submission data
Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials
selection and application of data acquisition standards
selection of quality risk indicators
third party study data due diligence
functional management of Associate Data Managers
training and development
and adequate resourcing of DMs at Asset/Study level
Ensures appropriate documentation across the lifespan of the study/asset
ensures the required study specific CDIS documents in the Trial Master File (TMF) are of high quality
development of TA specific standards
project management leadership to DM teams
managing issues at the study level
proactively communicating to Asset Lead and Management
key scientific and technical data management contribute to department level initiatives
effective reporting of study status and metrics to Management
Ensures work carried out on behalf of CDIS is in accordance with applicable SOPs and working practices
testing and implementation of clinical data collection tools
data management contact for regulatory inspections/audits
How You'll Work.
Team & Collaboration
Works with Asset Leads to establish strategy, timelines, and adequate resourcing of DMs at Asset/Study level; Provides project management leadership to DM teams; proactively communicating to Asset Lead and Management; key scientific and technical data management contribute to department level initiatives; data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups
Communication Scope
verbal and written communication skills
Process & Methodology
Project Management, Risk Management, project management leadership to DM teams, managing issues at the study level
Full Job Description
**ROLE SUMMARY** As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Manager, Senior Clinical Data Scientist (Sr CDS) is responsible for timely and high-quality data management deliverables supporting the Pfizer portfolio. The Sr 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 Sr 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 Sr CDS may have one or more direct reports. **ROLE RESPONSIBILITIES** * Serves as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence. * May functionally manage a team of Associate Data Managers, Senior Data Managers, be responsible for resource allocation, training and development. * Works with Asset Leads to establish strategy, timelines, and adequate resourcing of DMs at Asset/Study level. * Ensures appropriate documentation across the lifespan of the study/asset for all DM deliverables and ensures the required study specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. * May likely be involved in development of TA specific standards. * Provides project management leadership to DM teams – Responsible for managing issues at the study level as they arise and proactively communicating to Asset Lead and Managemen
Applying for this Manager, Senior Clinical Data Scientist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Pfizer?
Real rants from real employees. Read before you apply.