Clinical Trial Manager

ABOUT US: We are a physician-led clinical research program specializing in rheumatology and autoimmune diseases, supported by a well-established specialty practice with over 30 years of excellence in patient care. Our team conducts Phase 2–4 industry-sponsored trials in conditions such as Sjögren’s syndrome, gout, and systemic autoimmune diseases. With strong patient access and a growing research portfolio, we are advancing innovative therapies that improve outcomes for patients with complex rheumatologic conditions.

THE OPPORTUNITY: As Clinical Trial Manager, you will serve as the primary operational and strategic leader for all active and incoming clinical trials. You will work closely with the Principal Investigator, sponsor representatives, regulatory bodies, and a dedicated clinical team to ensure the highest standards of trial conduct, data integrity, and patient safety.

REQUIREMENTS: MD, DO, or international equivalent medical degree (required)Minimum 2 years of clinical trial management experience (required)Strong working knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes Proficiency with EDC systems, CTMS platforms, and essential document managementWHO YOU AREA strategic thinker who anticipates risks and develops proactive solutionsA self-starter who takes ownership without being told what needs to be done Energetic and enthusiastic with an unwavering commitment to excellence An exceptional communicator — written, verbal, and cross-functional Experienced collaborating with sponsors, CROs, IRBs, vendors, and internal teams Deeply knowledgeable about Good Clinical Practice (GCP) and research ethics Comfortable in a fast-moving, growth-oriented environment Possess a genuine growth mindset — you seek feedback, embrace challenges, continuously improve, and inspire the same in those around youRESPONSIBILITIESDevelop and manage the overall strategy, timeline, and execution of all active clinical trials Serve as the primary point of contact for sponsors, CROs, and regulatory bodies Oversee site-wide implementation and compliance with GCP standards Monitor and manage clinical trial team activities and protocol adherence Ensure all regulatory and ethical requirements — including IRB submissions and renewals — are met on time Collaborate with clinical, billing, pharmacy, and administrative teams to drive trial success Monitor and report trial progress to the PI and sponsor; escalate issues promptly Anticipate and mitigate operational, regulatory, and safety risks Build and maintain strong relationships with vendors, sites, and sponsors Ensure all trial documentation and the Investigator Site File (ISF) are complete and audit-ready at all times Develop, manage, and monitor clinical trial budgets; negotiate site payments, track expenditures, and ensure financial accountability across all active studiesCOMPENSATION &

Salary: $90,000 – $120,000, commensurate with experience and qualifications Sign-on bonus Full-time position with competitive benefits We also welcome applications from U.S.-trained and internationally trained medical graduates. TO APPLYSubmit your CV, a brief cover letter, and any relevant GCP certifications or trial experience documentation to: shannon@overlakearthritis.com