Clinical Operations Manager

Clinical Operations ManagerHands-on clinical operations leader responsible for day-to-day execution of TECLens's international clinical trials. This role owns site relationships, enrollment management, regulatory submissions, and operational support across active study sites in the Philippines, Dominican Republic, and Brazil. The Clinical Operations Manager ensures studies run smoothly, timelines are met, and site teams have the resources and support they need to succeed.Competitive, commensurate with experience. Details available upon request.Location: Stamford, Connecticut, USA (this is not a remote position)Up to 40% US and international travel to clinical sites (Latin America, Asia/Pacific)Must possess valid US passportExperienced clinical operations professional with a track record of managing multi-site US and international clinical trialsCreative, resourceful operator who finds practical ways to keep studies moving in complex international environmentsStrong relationship builder who can partner effectively with investigators, site coordinators, and local regulatory contactsUnderstands the difference between hard requirements (patient safety, data integrity, GCP) and administrative processes that require pragmatic navigationComfortable operating in ambiguous situations where the textbook answer may not be the right answerSelf-directed problem solver who thrives in a fast-paced startup environment with limited infrastructureStrong communicator who keeps leadership informed with clear, concise status updatesTECLens ( is developing a completely novel vision correction technology based on quantitative corneal crosslinking, or qCXL™. The qCXL™ system has 4 primary components:A single use disposable therapy delivery device that delivers therapeutic ultraviolet light (UV) and treatment monitoring ultrasound (US)A user interface console that houses the controlling computer and the UV and US systemsA photoactive drug that interacts with the UV to provide corneal strengthening that results in refractive changeA computational treatment planning suite (TPS) that calculates an optimized plan for each patient's specific needs and provides a control point that the US system monitors during the procedureThe Clinical Operations Manager will be the primary operational point of contact for clinical trial sites, ensuring that studies are executed according to protocol, enrollment targets are met, and regulatory filings are submitted on time.Manage Site Relationships serving as the primary day-to-day contact for investigators, coordinators, and site staff across all active clinical sitesDrive Enrollment by tracking screening and enrollment metrics, identifying barriers, and working with sites to implement solutionsManage Site Logistics including creative solutions to supply chain and import challenges in emerging marketsManage Clinical Data Flow by coordinating with sites on case report form completion, query resolution, and data qualityTrack and Report Study Metrics including enrollment, visit completion, protocol deviations, and adverse eventsCoordinate Site Training for new personnel and protocol amendmentsMaintain Trial Master File ensuring essential documents are collected, reviewed, and filed in a timely mannerSupport Monitoring Activities by preparing for and following up on monitoring visits, whether conducted internally or by CRO partnersBS in Life Sciences/Engineering, Nursing, Optometry or related field with 5+ years of clinical affairs or clinical operations experience in medical device or pharmaceutical clinical trials, including at least 2 years managing international (OUS) studies.Direct experience with regulatory submissions in Latin America (ANVISA, INVIMA, or similar)Experience with FDA IDE studies or international device trials highly desirableFamiliarity with ophthalmic clinical trials a plusWorking knowledge of GCP, ICH E6, and ISO 14155Experience with EDC systems and clinical trial management systemsSpanish and/or Portuguese language skills desirableStrong English written and verbal communication skillsVery proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, and PowerPoint