Description
Plan, direct, and coordinate clinical trials across phases I to IV, overseeing protocol development, site operations, regulatory compliance, data quality, patient safety, timelines, and budgets.
- • Collaborate with investigators, CROs, vendors, and regulators to plan, launch, and review clinical studies.
- • Manage sponsor and stakeholder communications; present study status, milestones, and outcomes.
- • Plan and direct trial operations from start-up through closeout across assigned protocols.
- • Develop study proposals, protocols, operational plans, and timelines.
- • Coordinate feasibility, site selection, initiation, monitoring, data review, and closeout activities.
- • Review study progress and quality metrics; author or approve monitoring reports and TMF documentation.
- • Hire, train, and supervise CRAs, CTAs, and site staff; evaluate performance and workload.
- • Translate clinical development objectives into detailed study plans, budgets, and KPIs.
- • Establish and enforce SOPs and quality standards to ensure GCP and regulatory compliance.
- • Implement and optimize eClinical systems (EDC, eTMF, ePRO, RTSM) and train teams and sites.
- • Oversee patient safety processes, informed consent, SAE reporting, and pharmacovigilance coordination.
- • Oversee regulatory and ethics submissions and approvals (IND/CTA, IRB/IEC) and maintain compliance throughout the study.
- • Drive site and patient recruitment and retention strategies; monitor enrollment against targets.
- • Prepare and manage study budgets; track spend and approve site and vendor payments.
- • Lead vendor and CRO oversight, risk management, audits, and inspection readiness; manage CAPAs.
- • Present study updates and results to internal leadership, investigators, and at professional meetings.
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
