Iterative Health
Cambridge, Massachusetts, United States, New York, New York, United States
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech‑enabled services. By combining deep expertise in clinical trials with cutting‑edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Position Location:
Remote
As the Manager, Clinical Operations you will report to the Director, Clinical Operations and work closely with our Clinical Research and Life Science teams. Your primary responsibility will be to engage with partners such as sponsors, CROs and key sites to drive executive operational alignment. You will provide strategic recommendations both internally and externally with a focus on improving research operations. Your day to day will include engaging with sponsors and CROs to report on study progress from site selection to close out. You are responsible for optimizing study performance through assessing gaps, identifying priorities for service(s) implementation and acting as a subject matter expert.
This is a key, customer facing role responsible for providing clinical research best practices and thought leadership to our sites and sponsors.
Key Responsibilities
Support regular sponsor/CRO/partner level meetings with operational clinical expertise and strengthen stakeholder engagement through building credibility and delivering against sponsor/CRO/partner needs
Ensure data currency to deliver desired insights and metrics to sponsors
Serve as a subject matter expert in clinical research and be a champion for sites
Support study selection, partnering with the Life Science team to review new study protocols and assess fit for our network
Collaborate with manager on protocol feedback to maximize site interest and performance
Manage customer relationships across a diverse group of stakeholders at sponsors, CROs and sites
Act as the voice of the customer and collect feedback to drive continuous improvement across all functional areas within IH
Work closely with sponsor and CRO to find efficiencies to optimize site activation timelines
Communicate risks clearly and recommend resolution strategies, escalating (both internally and externally) as appropriate
Identify blockers and trends, as related to site activations and recruitment and help cross‑functional teams troubleshoot
Facilitate fireside chats and webinars with customers
Travel as needed to conferences, investigator meetings and to support sponsors during site visits
Required Skills
At least 8 years experience with phase 2-4 pharma‑sponsored clinical trials, including study start‑up, CDA, feasibility, regulatory/standard operating procedures, study protocols, and regulations governing clinical research
Experience coordinating, evaluating, and following patients’ participation through clinical trials
Demonstrated ability to manage multiple projects, meet deadlines, manage risk and adjust priorities appropriately in a clinical study setting
Demonstrated stakeholder management skills
Capability to work with new tools and technology
Willingness to travel to customer sites (~30%)
Preferred Qualifications
Knowledge and experience in the GI & Hepatology clinical trial space
Prior project and/or program management experience
5+ years as a Clinical Research Associate, Clinical Research Coordinator or 3+ years as a Clinical Team Manager
Experience with CTMS systems – RealTime highly preferred
Experience working within a start‑up organization
What We Offer
Medical, dental, and vision insurance
Life and disability insurance
Parental leave
Stock options
Unlimited paid time off
Pay Range:
New York – $122,000 – $170,000 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, a hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
As set forth in Iterative Health’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
Voluntary self‑identification (for government reporting purposes) is entirely voluntary and will not be considered in the hiring process or thereafter.
#J-18808-Ljbffr
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech‑enabled services. By combining deep expertise in clinical trials with cutting‑edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Position Location:
Remote
As the Manager, Clinical Operations you will report to the Director, Clinical Operations and work closely with our Clinical Research and Life Science teams. Your primary responsibility will be to engage with partners such as sponsors, CROs and key sites to drive executive operational alignment. You will provide strategic recommendations both internally and externally with a focus on improving research operations. Your day to day will include engaging with sponsors and CROs to report on study progress from site selection to close out. You are responsible for optimizing study performance through assessing gaps, identifying priorities for service(s) implementation and acting as a subject matter expert.
This is a key, customer facing role responsible for providing clinical research best practices and thought leadership to our sites and sponsors.
Key Responsibilities
Support regular sponsor/CRO/partner level meetings with operational clinical expertise and strengthen stakeholder engagement through building credibility and delivering against sponsor/CRO/partner needs
Ensure data currency to deliver desired insights and metrics to sponsors
Serve as a subject matter expert in clinical research and be a champion for sites
Support study selection, partnering with the Life Science team to review new study protocols and assess fit for our network
Collaborate with manager on protocol feedback to maximize site interest and performance
Manage customer relationships across a diverse group of stakeholders at sponsors, CROs and sites
Act as the voice of the customer and collect feedback to drive continuous improvement across all functional areas within IH
Work closely with sponsor and CRO to find efficiencies to optimize site activation timelines
Communicate risks clearly and recommend resolution strategies, escalating (both internally and externally) as appropriate
Identify blockers and trends, as related to site activations and recruitment and help cross‑functional teams troubleshoot
Facilitate fireside chats and webinars with customers
Travel as needed to conferences, investigator meetings and to support sponsors during site visits
Required Skills
At least 8 years experience with phase 2-4 pharma‑sponsored clinical trials, including study start‑up, CDA, feasibility, regulatory/standard operating procedures, study protocols, and regulations governing clinical research
Experience coordinating, evaluating, and following patients’ participation through clinical trials
Demonstrated ability to manage multiple projects, meet deadlines, manage risk and adjust priorities appropriately in a clinical study setting
Demonstrated stakeholder management skills
Capability to work with new tools and technology
Willingness to travel to customer sites (~30%)
Preferred Qualifications
Knowledge and experience in the GI & Hepatology clinical trial space
Prior project and/or program management experience
5+ years as a Clinical Research Associate, Clinical Research Coordinator or 3+ years as a Clinical Team Manager
Experience with CTMS systems – RealTime highly preferred
Experience working within a start‑up organization
What We Offer
Medical, dental, and vision insurance
Life and disability insurance
Parental leave
Stock options
Unlimited paid time off
Pay Range:
New York – $122,000 – $170,000 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, a hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
As set forth in Iterative Health’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
Voluntary self‑identification (for government reporting purposes) is entirely voluntary and will not be considered in the hiring process or thereafter.
#J-18808-Ljbffr