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Tier-1 employer and metro location increase competition, while niche clinical-data specialization limits broad applicant pool.
Requires clinical trials data and regulatory experience, reducing transferability across unrelated industries.
No explicit years but specialized clinical-data, regulatory and inspection-readiness skills make shortlisting moderately strict.
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Coordinate and oversee all Clinical Data and Information Sciences (CDIS) deliverables for assigned clinical trials, ensuring adherence to data standards and quality of study datasets.
Lead, direct, and provide oversight to Data Managers on clinical trials; accountable for trial inspection readiness and quality/timeliness of CDIS deliverables.
Collaborate with cross-functional teams and external partners to implement operational excellence, applying CDIS best practices and ensuring regulatory compliance and study documentation quality.
Work Experience Required: Not explicitly mentioned in the JD.
Must ensure adherence to data standards, GCDMP guidelines, ALCOA principles, and applicable SOPs relevant to clinical trial data management.
Experience working with clinical trial data management, including oversight of data acquisition, management plans, and quality risk indicators.
Work Location: On Premise (Pfizer location)
Experienced in clinical trial data management with ability to lead cross-functional teams and manage complex data-related deliverables at the study level.
Skilled in regulatory compliance and quality assurance within clinical data environments, including trial master file documentation and inspection readiness.
Operationally focused leader capable of driving quality and efficiency to meet clinical study milestones in collaboration with internal and external stakeholders.