Senior Manager, Clinical Operations - GI

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 is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.

We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.

As the Senior Manager, Clinical Operations- GI at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health's mission of bringing innovative therapies to patients faster.

As Iterative Health continues to expand its Site Network and partnerships with sponsors and CROs, operational excellence has become a critical differentiator. This role sits at the center of those relationships, helping ensure studies are launched efficiently, sites are set up for success, and sponsors receive the insights and partnership needed to achieve their clinical development goals. In particular, this role will own and scale the site activation process across the organization. This role is responsible for driving on-time site activations within SLAs, proactively identifying and resolving blockers, and improving activation workflows to increase speed, predictability, and efficiency.

This is a highly visible, customer-facing role with the opportunity to influence study strategy, shape operational best practices, and drive measurable impact across a growing portfolio of clinical trials.

Where You’ll Drive Impact

Study Activation Ownership & Execution

• 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.

How We Work

• Collaborative and low-ego team environment
• High ownership and accountability culture
• Fast-paced and highly iterative growth environment
• Open communication and continuous learning mindset
• Mission-driven organization focused on improving patient outcomes
• Comfortable navigating evolving business priorities and opportunities

Benefits That Support You

We believe great teams do their best work when they feel supported — professionally and personally.

• Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office
• Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health
• Mental health and wellness support through Spring Health
• Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health
• Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years
• 401(k) program with a company match of up to 3% (up to $3,000 annually)
• Weekly in-office lunch benefit every Tuesday
• 100% company-paid short-term and long-term disability coverage
• Annual wellness and professional development stipend to support your health and growth
• And more!

New York pay range

$140,000—$165,000 USD

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact [e-mail].