Clinical Affairs Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, implement, and report on company-sponsored clinical studies that support IVD product submissions, label claims, clinical evidence generation, and post-market responsibilities.

• Develop and execute Clinical Affairs standard operating procedures (SOPs) and processes pertaining to study feasibility, protocol creation, IRB/EC submissions, informed consent, site qualification and initiation, monitoring, deviation management, safety reporting, data management interface, trial master file management, and study closure.

• Establish a structured trial master file, document control conventions, clinical training materials, and study templates that are integrated with the Quality Management System.

• Define frameworks for CRO and clinical vendor qualification, contracting, oversight, quality agreements, and performance metrics.

• Act as the operational lead on the sponsor side for ongoing clinical studies, which includes authorship of protocols, management of sites and vendors, monitoring oversight, escalation of deviations and safety events, and delivery of clinical study reports.

• Write and coordinate the clinical sections of 510(k), De Novo, PMA, IDE, CE technical documentation, IVDR performance evaluation reports, and other related regulatory submission materials.

• Monitor and communicate the status of studies, budgets, timelines, risks, and mitigation strategies to Regulatory leadership.

• Collaborate with Biostatistics, Data Management, Development, and Quality teams to ensure that clinical data are analyzable, traceable, inspection-ready, and prepared for submission.

• Serve as a liaison between Regulatory Affairs and Medical Affairs on matters related to clinical evidence, study design, intended claims, publication strategies, and planning for post-market evidence.

• Incorporate input from Medical Affairs into protocol development, results interpretation, clinical study report narratives, KOL/advisory input, and the creation of external presentations.

• Work alongside Marketing and Market Access to ensure that product claims are scientifically valid and traceable to clinical evidence.

• Maintain readiness for study inspections and ensure compliance with relevant GCP, 21 CFR Part 812, ISO 14155, ISO 20916, IVDR, and similar international standards.

• Keep abreast of evolving FDA, IVDR, ICH, and CLSI expectations and suggest updates to SOPs, templates, and study practices as necessary.

• Mentor upcoming Clinical Affairs hires as the function grows, without direct-report responsibilities unless formally adjusted.

• Perform any additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in life sciences, engineering, clinical disciplines, or a related scientific field; advanced degree is preferred.

• Over 7 years of experience in clinical affairs, clinical operations, or clinical research within the medical device, IVD, diagnostic, or molecular diagnostics industry; 5+ years may be considered with an advanced degree.

• Direct, hands-on experience managing sponsor-side clinical studies in accordance with GCP and one or more applicable clinical study frameworks, such as 21 CFR Part 812, ISO 14155, or ISO 20916.

• Proven experience in authoring clinical sections of FDA submissions and/or CE/IVDR technical documentation.

• Experience in building or significantly enhancing Clinical Affairs SOPs, templates, trial master file structures, or related clinical study infrastructure.

• Experience with oversight of CROs and clinical vendors, including quality agreements, issue escalation, and vendor performance management.

• Familiarity with biostatistics, clinical data management, electronic data capture systems, and clinical evidence generation.

• Exceptional scientific writing, cross-functional communication, and project management abilities.

• Adaptive is not currently sponsoring candidates who require work authorization support for this position.

🏝️ Benefits

• Equity grant.

• Bonus eligibility.

• Occasional domestic and international travel for clinical site visits, investigator meetings, vendor oversight activities, audits/inspections, conferences, and cross-functional business meetings.

• Comprehensive benefits package from Adaptive (details available via benefits-at-a-glance link).