Senior Manager, Clinical Operations

Responsibilities

• Contribute to one or more clinical studies; collaborate with cross‑functional clinical study teams to support delivery.
• Evaluate and ensure appropriate oversight of CROs and external vendors.
• Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
• Establish and maintain effective communication/collaboration with functional peers to meet study objectives.
• Identify risks and propose solutions to facilitate clinical studies.
• Review and oversee study‑level budgets; manage contract/work order changes; support budget forecasting and accruals with Finance.
• Oversee and manage creation, maintenance, QC, and closeout of TMF activities.
• Ensure oversight of enrollment, site activation, and data collection milestones.
• Support completeness of study documents (protocol, investigator brochure, informed consent forms, clinical study reports, case report forms).
• Collaborate with Data Management to ensure timely database lock; participate in data review and reconciliation.
• Lead or co‑lead department initiatives.
• Travel may be required (10%–15%).

• Detail‑ and process‑oriented; strong project management including risk assessment and contingency planning.
• Excellent problem‑solving, communication, and organization.
• Flexibility with changing priorities; critical thinking; strong attention to detail; works well under pressure.
• Collaborative; builds effective relationships across the organization.
• Demonstrated leadership; strategic planning and ability to manage multiple projects simultaneously.

• 5–7+ years of Clinical Operations experience.
• Bachelor’s degree or higher in a scientific/healthcare discipline preferred; relevant biotech/pharma/CRO experience.
• Extensive knowledge of current ICH‑GCP guidelines.
• Experience managing early through late Phase clinical trials.
• Demonstrated cross‑functional leadership and ability to motivate teams.
• Ability to challenge status quo using a risk management approach.
• Ability to thrive in a remote/virtual environment.

• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement savings plan, and generous paid time off (including summer and winter company shutdown).