Senior Manager, Clinical Operations

United States·Cambridgesenior

OtherClinical Operations

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Quick Summary

Overview

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

Technical Tools

OtherClinical Operations

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.

Responsibilities

~1 min read

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

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 30%).

Monitor study performance metrics and own activation-specific reporting, including time-to-activation, SLA performance, and root causes of delays
Analyze and provide feedback to sponsor/CRO on slower-than-expected enrollment, high screen fail rates, and/or variability in site performance
Use data to inform prioritization and process improvements
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

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%.

Requirements

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Experience in GI clinical research
Prior project or program management experience.
5+ years of experience as a Clinical Research Associate (CRA) , or 3+ years leading clinical operations teams.
Experience working in a high-growth or startup environment.
Experience presenting to sponsors, CRO leadership, and executive stakeholders.