Pfizer

Biopharmaceutical

Manager,SeniorClinicalDataScientist

Greece FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Biopharmaceutical
Problems you'll solve

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

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