Overview
Manager, Clinical Data Scientist, Clinical Data Sciences role at Pfizer. The Clinical Data Scientist represents the Clinical Data and Information Sciences (CDIS) group at the study level, coordinating all CDIS deliverables for a clinical trial, ensuring data standards and quality of study data sets, and providing leadership and oversight to Data Managers. The role is accountable for inspection readiness of the trial.
What You Will Achieve
In this role, you will:
* Serve as Clinical Data Scientist for one or more clinical trials, taking responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third party study data due diligence.
* As a Core Study Team member, drive operational excellence in collaboration with cross-functional partners through CDIS best practices at the study level; act as a technical resource on how to best collect, process, consume and report clinical trial data.
* Be accountable for the quality and timeliness of all CDIS deliverables in support of the clinical trial; partner with Research/Business Units, external data/service providers and internal CDIS staff to deliver high quality data management for all studies as assigned.
* Proactively drive quality and efficiency to meet study/asset timelines, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross-functional study team. Ensure work carried out by/on behalf of CDIS complies with applicable SOPs and work practices; assure adherence to regulations, standards, GCDMPs, ALCOA principles by the team you coordinate.
* Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and filed contemporaneously.
* Work with Asset Leads to establish strategy, timelines, and adequate resourcing of the study.
* Provide leadership, direction and oversight to the CDIS resources working on the clinical trial(s).
Minimum Requirements
* Working knowledge of all phases of clinical trials and ability to assess and determine study requirements from protocol review; strong project and risk management.
* Proven Clinical Data Management experience.
* Strong verbal and written communication skills.
* Consistent, detail oriented, communicative, dedicated to excellence.
* CRO and vendor oversight experience preferred.
* Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
* Proficiency with commercial clinical data management systems and/or EDC products (e.g. Medidata RAVE, Oracle RDC / InForm, etc.).
* 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, PowerPoint, etc.).
* Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
Work Location Assignment: Remote.
The closing deadline for applications is September 21st.
All applicants must have the relevant authorisation to live and work in the UK.
Culture and Equality
Purpose: Breakthroughs that change patients’ lives. Pfizer is a patient-centric company guided by values: courage, joy, equity and excellence. We are committed to a diverse and inclusive workforce and to empowering our employees. We are a Disability Confident Employer and will make reasonable adjustments to support your application and career.
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