Clinical Operations Manager(Biological Sample Clinical Trials)

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.

As the Clinical Operations Manager, you will report to the VP, Growth and work closely with our Clinical Research and Life Sciences teams to integrate Iterative Health (IH) services and AI solutions at clinical research sites throughout the US. This external-facing role will require strong communication, customer engagement and deep expertise in clinical research, in addition to a strong strategic skill set. You will engage with partners such as sponsors, CROs and key sites to drive executive operational alignment, providing strategic recommendations both internally and externally with a focus on improving research operations focused on biological sample collections trials. You’ll also be working directly with your portfolio of sites to deliver day-to-day support that encourages research best practices, drives the adoption of IH services and products, and ensures our sites achieve their research goals.

Key Responsibilities:

• Own end-to-end clinical research operations for biological sample collections trials, serving as the primary accountable party for trial execution quality and sponsor satisfaction outcomes

• Build and manage DCT (decentralized clinical trial) vendor relationships, including performance management, metrics tracking, and oversight to ensure biological sample collections trial delivery

• Own the information flow between sites and sponsors - including internal study education, site engagement protocols, and issue escalation pathways

• Serve as leading sponsor-facing owner for active studies - leading alliance management meetings by providing study updates, reviewing metrics, discussing site accomplishments and ongoing issues, and gathering information to relay to site-based staff, driving sponsor satisfaction, and owning escalation resolution

• Drive direct QC enforcement with site CRCs/staff, including data quality expectations-setting and direct communication on compliance gaps

• Own site performance improvement through metrics, change management, and direct intervention - proactively identifying and resolving performance gaps before sponsor escalation

• Demonstrate advanced knowledge of clinical research processes and tools, such as CTMS, pre-screening, and/or feasibility, and enhance these processes and outputs to effectively support our sites or internal teams.

• Serve as a subject matter expert on clinical research workflows, in line with specific requirements of each protocol, optimized with Iterative Health (IH) services and AI solutions

• Support and lead weekly meetings with site-based staff to review enrollment progress, address operational issues, and provide guidance for performance improvement.

• Manage customer relationships with a high degree of professionalism and expertise ensuring timely responses, escalations of site issues, and building trust needed to help sites achieve IH goals

• Leverage IH solutions and services to help build best practice research sites, accelerate clinical trials, and build capacity at IH sites to execute high-quality clinical trials.

• Deliver customized training for different clinical research user groups and devise process maps/workflows, tools, and techniques to help sites incorporate IH services

• Travel to customer sites to support study site activation, drive patient screening, and standby support for randomization activities

• Collect, analyze, and communicate the voice of IH customer successes, concerns, and product adoption issues/competency gaps and collaborate with IH cross-functional teams to design and deliver solutions

Required skills:

• BS/BA or higher degree.

• Minimum 4 years of clinical research coordinator experience

• At least 8 years of experience with biological sample collection trials and/or 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.

• Fluent in the use of Microsoft Office/Google Apps products.

• Ability to navigate ambiguity and willingness to be flexible/adapt to changing work environments.

• Desire to work with new tools and technology

• Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately.

• Willingness to travel to customer sites (~30%)

Preferred skills:

• 5+ years as a Clinical Research Coordinator (CRC) working with biological sample collections trials or equivalent experience

• Experience with CTMS systems - preferably RealTime, Clinical Conductor, or CRIO

New York pay range
$125,000—$150,000 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 [email protected].