As part of the Data Monitoring and Management group, an integral delivery unit within the Global Product Development (GPD) organization, the Clinical Data Scientist is responsible for timely and high quality data management deliverables supporting the Pfizer portfolio. The Clinical Data Scientist designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.
Clinical Data Scientist
- Serve as Clinical Data Scientist for one or more clinical trials assuming responsibility for all DM&M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
- 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.
- Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting
- Partners with Research/Business Units and any external DM service provider 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 DM providers is in accordance with applicable SOPs and working practices.
- Ensure the required study-specific DM&M 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.
- Proficient experience using Oracle Inform EDC software
- Experience with Oracle DMW preferred
- Working experience applying CDISC CDASH standards
- 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
- Experience using 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 or at least 15 years of relevant data management experience.