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Tier-1 brand but niche clinical-trials specialization reduces applicant density.
Clinical-trials data expertise and regulatory knowledge limit cross-industry transferability.
Regulated clinical trials environment and managerial accountability drive strict, domain-specific hiring filters.
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Coordinate all Clinical Data and Information Sciences (CDIS) deliverables for one or more clinical trials, ensuring data standard adherence and quality of study data sets.
Lead and provide oversight to Data Managers and CDIS resources, accountable for trial inspection readiness and deliverable timeliness.
Collaborate as a Core Study Team member to implement CDIS best practices, manage external/internal partnerships, and drive operational excellence and quality risk indicators.
Experience in clinical data management within clinical trials: Not explicitly mentioned in the JD; managerial experience implied by 'Manager' title and oversight responsibilities.
Knowledge and application of data acquisition standards, GCDMPs, ALCOA principles, and regulatory compliance required.
Ability to coordinate documentation in Trial Master File (TMF) ensuring study-specific CDIS documents are high quality and contemporaneous.
Work Location: On Premise (Pfizer site)
Experienced in managing and leading clinical data science teams across multiple studies with strategic oversight of data management deliverables.
Strong collaborator within cross-functional clinical development teams, capable of driving operational excellence and risk-based quality management.
Skilled in regulatory and quality standards compliance, with a focus on inspection readiness and scientific rigor in clinical trial data handling.