IVD & CLIA Waiver - Clinical Trials Manager

Sr. Manager, Clinical Trials Strategy & Operations - USA Location: Remote (U.S.-based) Travel: Up to 25–30% (domestic & occasional international) Position Type: Full-Time Our client, a well-funded, fast-growing diagnostics startup (5+ years in operation), is seeking a Senior Manager, Clinical Strategy and Operations for a REMOTE with travel This is a full-time, permanent role with competitive compensation (salary + benefits + RSUs). Location & Work Arrangement Estimated travel: ~25 – 30 % Mostly Remote Hands on experience with In Vitro Diagnostics (IVD) - current or recent experience. working knowledge of CLSI & FDA standards/ guidelines to draft the trial and analytical study protocols, help draft CRFs, and lead the trial. CLIA-Waiver Experience Hands on experience writing clinical and analytical study protocols, trial reports and managed sites. You are a strategic and hands-on leader with deep expertise in clinical trial strategy and operations, passionate about advancing innovative diagnostics that improve patient care. You excel at driving the execution of complex clinical trial programs, building strong cross-functional relationships, and ensuring operational excellence from study design through completion. Your background includes significant experience in clinical operations leadership within invitro diagnostics settings, and you thrive in fast-paced, multidisciplinary environments. You are excellent in scientific and clinical writing and communication skills. You are committed to quality, compliance, and the development of high-performing teams. Ability to travel domestically and internationally as required (up to 25-30%). Experience Needed Bachelor’s degree in a scientific or health-related discipline required; advanced degree (MS, MPH, PharmD, PhD or equivalent) preferred. 8+ years of progressive experience in clinical strategy and operations within the invitro diagnostics devices Must have CLIA-waiver experience Experienced in successfully executing clinical trials for 510(k) and CLIA-waiver (dual submission preferred) for IVD devices for hematology, clinical chemistry or immunoassays Proven expertise in managing all aspects of clinical trials, including CRO/vendor oversight, site management, and operational budgeting. Excellent proven clinical writing and communication skills In-depth knowledge of ICH/GCP guidelines, FDA, CLIA, EMA, and global regulatory requirements for clinical research. Demonstrated ability to lead, inspire, and develop high-performing teams in a cross-functional, matrixed environment. Strong project management, organizational, and problem-solving skills, with a track record of delivering complex projects on time and within budget. Excellent interpersonal, written, and verbal communication skills, with the ability to influence and collaborate at all levels of the organization. Proactive, innovative, and adaptable, with a commitment to continuous learning and operational excellence. Experience in IVD medical devices, Familiarity with CLIA-waived devices and regulatory requirements Prior experience in a high-growth or start-up biotech environment. Responsibilities: Lead the planning, execution, and oversight of global clinical trials ensuring alignment with organizational strategy, timelines, and budgets. Lead the clinical trial protocol development and modifications through the clinical trial lifecycle Serve as the primary point of contact for operational management of clinical development strategy, collaborating closely with regulatory, medical affairs, and commercial teams. Oversee the selection, management, and performance of clinical trial sites, CROs, and clinical vendors, functional service providers to ensure high-quality execution and compliance with GCP, ICH, and regulatory requirements. Develop and implement clinical operations SOPs, guidelines, and best practices to optimize efficiency, quality, and compliance. Lead clinical trial site training, initiation and coordination Monitor clinical trial progress, including site activation, patient enrollment, data collection, and study close-out, proactively identifying and mitigating operational risks. Lead the development and management of clinical trial budgets, timelines, and resource planning, ensuring deliverables are met within scope and cost constraints. Guide the preparation and review of operational sections of regulatory submissions (e.g., 510k, CLIA-waiver, dual submissions, IVDR) and support interactions with health authorities. Synthesize operational data and KPIs to inform program strategy and decision-making, providing regular updates to senior leadership. Ensure timely and accurate documentation and reporting of all clinical operations activities, maintaining inspection readiness at all times. Own the Clinical Trial Master File for the completion and future potential audits Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors. Also, the client Will Require 3 professional Work References to be completed prior to offer. If you are interested, please send me your updated Word Resume, along with your direct phone number and email.