"o Assisted in project planning activities, including developing timelines, allocating resources, tracking budgets, and ensuring deliverables were completed on time and within financial targets.
Coordinated with Project Managers, Investigators, and Sponsors.
Maintained Trial Master File and ensured regulatory compliance.
Submitted expedited reports to regulatory authorities and sponsors.
Assisted in developing project timelines and resource allocation plans for PV activities (case processing, SAE reconciliation, regulatory submissions).
Experience in data processing, reconciliation, quality control, and regulatory/compliance reporting across multiple projects and stakeholders.
Maintained dashboards, status reports for senior management.
Prepared status reports, SOPs, and supported audits
Coordinated with cross-functional teams (Data Management, QA & Regulatory) to ensure deliverables are on schedule.
Tracked risks, escalated critical issues, and assisted in implementing CAPA and risk management plans to ensure patient safety compliance.
Maintained governance by following established processes, documenting activities, monitoring compliance, and ensuring accountability for project outcomes.
Assisted in preparation for internal audits and inspections."
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Job Types: Full-time, Fixed term contract
Contract length: 12 months
Pay: $37.59-$55.08 per hour
Work Location: In person
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