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Immunocore · 1 week ago

Director of Data Management, Technical Operations & Standards

Radnor, PA

Full-time

Onsite

Director/Executive

16+ years exp

Immunocore is a pioneering biotechnology company focused on developing transformative medicines for oncology, infectious diseases, and autoimmune diseases. The Director of Data Management will oversee the design, integration, and governance of eClinical systems, ensuring regulatory compliance and operational efficiency throughout the clinical development data lifecycle.

BiotechnologyHealth CareMedicalPharmaceutical

Responsibilities

Lead and manage the eClinical strategy for clinical trials, ensuring adherence to industry standards and regulatory requirements

Support the implementation and maintenance of EDC, eCOA, ePro and other clinical systems, ensuring efficient data capture and processing

Lead study start‑up planning, CRF standards, edit check strategy, and database lock processes

Track the performance of EDC vendors, systems, proactively identify and resolve issues, and ensure studies are setup and designed per protocol

Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and ICH guidelines. Oversee system validation per 21 CFR Part 11, GxP, and GDPR compliance

Promote AI and automation for query optimization, edit check generation, and data review

Develop and oversee eClinical data governance for metadata, CDISC standards, and controlled terminology Ensure the integrity and quality of clinical data through rigorous validation and monitoring processes

Oversee vendor management; Partner with groups across Clinical Development, and IT, to select, qualify, and manage external eClinical vendors, ensuring compliance with regulatory and quality standards

Oversee inspection readiness activities, including audits and regulatory inspections related to clinical trial conduct

Other duties as needed

Qualification

EClinical systemsMedidata RaveClinical data managementCDISC standardsFDA guidelinesData validation processesAnalytical skillsEntrepreneurial mindsetLeadership experienceProblem-solving skillsCommunication skills