RemoteFull timeMid levelPosted today
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Key Responsibilities:
Pivotal Studies Support the planning and execution of neurology clinical programs, including CIDP, through:
- Review of adjudication charters, endpoint assessment manuals, and related operational plans
- Identification of clinical trial execution risks, operational gaps, and potential barriers to enrollment, data quality, and study delivery
- Review of study start-up, site activation, enrollment, monitoring, vendor oversight, and participant-retention strategies
- Assessment of protocol operational feasibility and support for protocol development and pivotal-study planning
- Review of clinical data, protocol deviations, missing data, and emerging study trends to identify potential quality or execution concerns
- Evaluation of site and vendor performance, including escalation pathways, roles and responsibilities, and operational accountability
- Support for development of risk-mitigation plans, issue-management processes, and corrective and preventive actions, as appropriate
- Cross-functional collaboration with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors
- Support for regulatory preparation and inspection- or submission-readiness activities
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