Senior Clinical Trial Manager

The Opportunity

A growing biotechnology organization is seeking an experienced clinical operations professional to oversee the practical delivery of active studies and help prepare upcoming trials. This individual will connect internal stakeholders with outsourced research partners, maintain accountability for execution, and keep study activities aligned with schedule and financial expectations.

This is a highly engaged, site-facing position rather than a purely desk-based oversight role. The successful candidate will be comfortable visiting research centers, working directly with investigators and coordinators, identifying bottlenecks, and driving workable solutions.

What You Will Do

• Coordinate trial activity at participating research centers, including activation, enrollment, ongoing operations, site milestones, and site-level spending.
• Oversee the daily work of contract research organizations and other service providers; evaluate deliverables, address missed commitments, and elevate significant concerns with recommended next steps.
• Guide site initiation and the operational rollout of protocol revisions, ensuring associated documents, agreements, training, technology, and budgets are updated.
• Use study indicators covering start-up, patient screening, accrual, trial conduct, and data delivery to recognize trends and organize risk mitigation.
• Conduct visits to clinical sites, sometimes with CRO representatives, to assess patient pathways, meet study personnel, and remove obstacles to performance.
• Partner with clinical operations and site-engagement teams to carry out location-specific participant recruitment initiatives and measure their effectiveness.
• Review study-related financial activity, including vendor billing, projections, scope changes, and site agreement adjustments; collaborate with finance and legal on discrepancies.
• Monitor completeness of essential records and electronic trial master files; partner with quality and external teams to address deficiencies and support audit preparedness.
• Facilitate cross-functional operating discussions, communicate decisions and action items, and maintain visibility into unresolved site and partner issues.
• Contribute to feasibility assessments, selection of outside providers, planning for new protocols, and scalable clinical operations practices.

What You Bring

• Bachelor's degree in life sciences, nursing, healthcare, or a comparable field; graduate education is a plus.
• At least five years in clinical research, with demonstrated ownership of trial management activities and study execution.
• Experience directing CROs or external vendors, either in a sponsor environment or in a CRO leadership capacity, and familiarity with sponsor oversight.
• Exposure to site activation, trial conduct, amendment implementation, and study closeout.
• Firsthand experience visiting research sites and collaborating with investigators and study coordinators; a background as a CRA or site coordinator is desirable.
• Understanding of clinical site workflows and participant logistics, with confidence engaging physicians and site personnel; nursing experience is beneficial.
• Ability to manage study schedules, costs, and risks while personally following operational problems through resolution.
• Working knowledge of Good Clinical Practice and clinical platforms including CTMS, eTMF, and EDC.
• A resourceful, detail-oriented approach suited to a smaller biotechnology setting, with strong communication and project coordination skills.
• Experience in obesity, cachexia, metabolic disorders, oncology, or multinational studies is advantageous.
• Availability to travel to study locations and attend investigator and external-partner meetings.