Senior Clinical Data Manager leading end-to-end clinical data management for global studies. Ensuring data quality and compliance, collaborating with stakeholders in a remote setup.
Responsibilities
Serve as the primary study‑level Data Management (DM) lead or co‑lead, providing strategic direction for all DM activities.
Provide day‑to‑day oversight and guidance to Clinical Data Managers, Clinical Data Coordinators, and/or Data Associates.
Lead internal study team meetings and contribute to sponsor meetings.
Track study progress, identify risks, and implement corrective and preventive actions.
Support financial oversight by monitoring study budgets for DM activities and tracking deliverables against the Scope of Work (SOW).
Ensure all DM deliverables meet internal quality standards, regulatory expectations, and contractual timelines.
Collaborate with the programming teams to enhance efficiency, streamline processes, and support innovation initiatives.
Requirements
A minimum of 6 years of hands‑on experience in the Clinical Data Manager project lead role, preferably in global Phase II–III oncology trials, with a CRO background.
Proven end‑to‑end data management lifecycle expertise, including database build, data cleaning, medical coding, SAE reconciliation, data review, and database lock.
Strong understanding of CDISC standards (SDTM), ICH‑GCP, regulatory requirements, and industry best practices.
Experience working with leading EDC systems (e.g., Medidata Rave, Inform, Veeva, or equivalent).
Advanced problem‑solving skills and a proactive, solution‑oriented approach to challenges.
Proven ability to plan, coordinate, and organize complex tasks with precision and attention to detail.
Experience contributing to budget tracking or financial oversight within study operations is beneficial.
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