Clinical Operations Lead – GI Studies & Activation

Iterative Scopes; Massachusetts; Hybrid; USD 140,000 - 165,000; Full time

Benefits offered by this job

Hybrid work in NYC or Boston

Medical, dental & vision coverage

Wellness stipend

401(k) with company match

PTO and holidays

Job summary

Iterative Health in New York/Boston area seeks a Senior Manager in Clinical Operations focused on GI. You will own site activations, coordinate trials with sponsors and CROs, and drive operational excellence across the network.

You will lead activation workflows, monitor performance, and provide insights to accelerate timelines while ensuring quality and regulatory compliance. Travel up to 30% is expected.

Qualifications

• 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.
• Willingness to travel up to 30%.
• Experience in GI & Hepatology clinical research preferred.
• Project/Program management experience or CRA/CRC leadership experience.
• CTMS experience, with RealTime CTMS strongly preferred.
• Experience in a high-growth or startup environment.
• Experience presenting to sponsors, CRO leadership, and executive stakeholders.

Responsibilities

• Own end-to-end site activations, managing timelines, dependencies, and risks across multiple sites and trials.
• Help teams prioritize tasks and ensure milestones are met within SLAs.
• Maintain activation plans, status tracking, and documentation, escalating risks and delays proactively.
• Serve as the primary operational partner to sponsors, CROs, and sites throughout the trial lifecycle.
• Lead sponsor, CRO, and partner meetings with clinical operations insights and strategic recommendations.
• Build relationships with stakeholders and align on study goals and metrics.
• Communicate study risks, mitigation plans, and escalation strategies.
• Facilitate educational sessions, webinars, and customer forums.

Skills

Analytical

Communication

Stakeholder management

Project management

Education

Bachelor's degree or equivalent

Tools

CTMS platforms

RealTime CTMS

Job description

Iterative Health in New York/Boston area seeks a Senior Manager in Clinical Operations focused on GI. You will own site activations, coordinate trials with sponsors and CROs, and drive operational excellence across the network.

You will lead activation workflows, monitor performance, and provide insights to accelerate timelines while ensuring quality and regulatory compliance. Travel up to 30% is expected.