GI Clinical Operations Lead — Site Activation

Iterative Health

Southlake (TX)

Hybrid

USD 140,000 - 165,000

Full time

8 days ago

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Benefits offered by this job

Hybrid work NYC/Boston
Medical, dental, vision
Spring Health
Health HSA/FSA
Unlimited PTO
Company Holidays
401(k) match
Lunch benefit
Disability coverage
Wellness stipend

Job summary

Iterative Health is seeking a Senior Manager, Clinical Operations- GI to drive end-to-end site activations and coordinate with sponsors, CROs, and investigative sites across multiple trials. You will own activation timelines, dependencies, and risk management to ensure timely study starts and strong site performance.

You will partner with sponsors and CROs to provide operational insights, optimize startup processes, and lead meetings with actionable recommendations.

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 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.
  • Willingness to travel up to 30%.

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.
  • 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%).
  • 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.

Skills

Clinical operations
Sponsor management
CRO liaison
Project management
GCP knowledge
Travel up to 30%

Education

Bachelor's degree

Tools

RealTime CTMS

Job description

Iterative Health is seeking a Senior Manager, Clinical Operations- GI to drive end-to-end site activations and coordinate with sponsors, CROs, and investigative sites across multiple trials. You will own activation timelines, dependencies, and risk management to ensure timely study starts and strong site performance.

You will partner with sponsors and CROs to provide operational insights, optimize startup processes, and lead meetings with actionable recommendations.

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