Senior Manager, Clinical Operations - GI

Roles and Responsibilities:

• Own the end-to-end site activations, managing timelines, dependencies, and risks across multiple concurrent sites and trials
• Help teams prioritize tasks and ensure milestones are met within defined SLAs
• Maintain activation plans, status tracking, and documentation, escalating risks and delays proactively

Sponsor & CRO Partnership

• Serve as the primary operational partner to sponsors, CROs, and sites throughout the trial lifecycle
• Lead and support sponsor, CRO, and partner meetings by providing clinical operations expertise, actionable insights, and strategic recommendations.
• Build strong relationships with key stakeholders and ensure alignment on study goals, performance metrics, and operational priorities.
• Proactively communicate study risks, mitigation plans, and escalation strategies
• Facilitate educational sessions, webinars, and customer forums to strengthen engagement and share best practices.
• Travel as needed to customer sites, investigator meetings, conferences, and sponsor engagements (up to 15%).

Study Performance & Operational Excellence

• Monitor study performance metrics and own activation-specific reporting, including time-to-activation, SLA performance, and root causes of delays
• Build and maintain dashboards that provide clear stakeholder visibility
• Use data to inform prioritization, process improvements, and resourcing decisions
• Identify operational gaps affecting site activation, enrollment, and execution, and collaborate cross-functionally to address them
• Advocate for site needs and serve as a subject matter expert in clinical research operations
• Collaborate cross-functionally to implement solutions that improve site performance and study outcomes.
• Partner with sponsors and CROs to streamline processes and optimize site activation timelines.
• Performs related duties as requested

What You Bring to the Team

• Bachelor's degree or equivalent combination of education and experience.
• 8+ years of experience supporting Phase II-IV sponsor-funded clinical trials.
• Deep understanding of clinical trial operations, including study startup, feasibility, regulatory processes, protocol execution, and GCP requirements.
• Experience working directly with sponsors, CROs, investigative sites, and cross-functional stakeholders.
• Demonstrated ability to manage multiple priorities, navigate ambiguity, and drive projects to successful completion.
• Strong analytical, communication, and stakeholder management skills.
• Comfort adopting and leveraging new technologies and operational tools.
• Willingness to travel up to 30%.

Preferred Qualifications

• Experience in GI & Hepatology clinical research.
• Prior project or program management experience.
• 5+ years of experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC), or 3+ years leading clinical operations teams.
• Experience with CTMS platforms, with RealTime CTMS strongly preferred.
• Experience working in a high-growth or startup environment.
• Experience presenting to sponsors, CRO leadership, and executive stakeholders.