Senior Manager- Clinical Operations

About the position 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. 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 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.

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
• Identifying blockers and trends, as related to site activations and recruitment and helping 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

Requirements

• 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%)

Nice-to-haves

• 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

Benefits

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off

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