<section id="comp-l76soz3j1" class="_3d64y"> <div class="_1uldx" data-testid="columns"> <div id="comp-l76soz3l1" class="_1vNJf"> <div class="" data-mesh-id="comp-l76soz3l1inlineContent" data-testid="inline-content"> <div data-mesh-id="comp-l76soz3l1inlineContent-gridContainer" data-testid="mesh-container-content"> <div id="comp-l76soz452" class="_2Hij5 _3bcaz" data-testid="richTextElement"> Company Overview At Aditum Bio, our mission is to rapidly translate scientific discoveries into new medicines. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need. Position Summary The Senior Manager, Clinical Operations will play a key role in the planning, execution, and oversight of early-stage clinical trials across assigned Aditum Bio portfolio companies. Reporting to the Senior Director, Clinical Operations, this individual will serve as an operational lead for one or more Phase I and Phase II studies, partnering closely with internal cross-functional teams and external CROs to ensure studies are conducted efficiently, compliantly, and with a high standard of quality. This is a hands-on role that requires strong operational execution, vendor oversight, and the ability to thrive in a fast-paced, lean biotech incubator environment supporting multiple portfolio companies. Responsibilities Study Leadership & Execution <ul> <li>Lead day-to-day operational management of Phase I–II clinical trials across one or more portfolio companies.</li> <li>Partner with the Senior Director, Clinical Operations to execute study strategy, timelines, and risk mitigation plans.</li> <li>Develop study plans, enrollment forecasts, recruitment strategies, and tracking tools.</li> <li>Manage study start-up, including site feasibility and selection, regulatory/ethics submissions, vendors, investigator meetings, and patient enrollment.</li> <li>Monitor study performance, identify and escalate risks, and implement mitigation plans.</li> <li>Review monitoring reports, protocol deviations, vendor deliverables, and study metrics to ensure quality oversight.</li> </ul> Vendor & Cross-Functional Partnership <ul> <li>Oversee CROs and vendors to ensure quality, timelines, budgets, and contractual deliverables are met.</li> <li>Serve as the primary study clinical operations lead, partnering with Clinical Development, Biometrics, Data Management, Regulatory, Quality, and other functions.</li> <li>Lead study team and vendor governance meetings, driving accountability and timely issue resolution.</li> </ul> Quality, Compliance & Data Oversight <ul> <li>Oversee studies from start-up through database lock and closeout, ensuring ICH-GCP compliance and inspection readiness.</li> <li>Partner with the eTMF manager and CRO to maintain a complete, current, and inspection-ready TMF.</li> <li>Support clinical trial audits and inspections.</li> <li>Participate in review of patient profiles, tables, listings, and figures.</li> </ul> Budget & Process <ul> <li>Suppor

Senior Clinical Trial Manager

Job Description