Responsibilities
- Lead planning, initiation, execution, and close-out of complex Phase I oncology trials; ensure compliance with protocol, SOPs, GCP, and applicable regulations.
- Manage external partners (CROs, central labs, biometrics, safety vendors, eTMF providers, etc.) to meet timelines, budget, and quality.
- Manage, mentor, and support direct reports.
- Participate in site selection, feasibility assessments, and initiation visits; build relationships with investigators/site staff to support enrollment and high-quality data.
- Oversee development/review of study documents (protocols, informed consent forms, CRFs, monitoring plans, study manuals).
- Review monitoring reports; ensure timely issue resolution and documented sponsor oversight to CRO monitors.
- Conduct data reviews, support data cleaning, and maintain inspection readiness (including regular TMF review).
- Collaborate with finance/legal on budgets, vendor invoices, and contract/change order negotiations.
- Partner with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and CMC to align execution.
- Guide junior team members; share best practices and drive process improvement.
- Prepare and deliver study updates/metrics/presentations; represent Clinical Operations in meetings.
- Contribute to SOPs/work instructions/operational tools; travel up to 15%.