Takeda Clinical Operations Manager Jobs (NOW HIRING)

Company:

TECLens is a small medical technology company with an entrepreneurial mindset and culture. We dream up and invent transformational solutions to vision care challenges facing hundreds of millions of people. We are looking for highly skilled, motivated, creative and dependable contributors to join our team.

Position Description:

Hands-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.

Compensation:

Competitive, commensurate with experience. Details available upon request.

Location and Travel:

• 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 passport

General Candidate Description:

• Experienced clinical operations professional with a track record of managing multi-site US and international clinical trials
• Creative, resourceful operator who finds practical ways to keep studies moving in complex international environments
• Strong relationship builder who can partner effectively with investigators, site coordinators, and local regulatory contacts
• Understands the difference between hard requirements (patient safety, data integrity, GCP) and administrative processes that require pragmatic navigation
• Comfortable operating in ambiguous situations where the textbook answer may not be the right answer
• Self-directed problem solver who thrives in a fast-paced startup environment with limited infrastructure
• Strong communicator who keeps leadership informed with clear, concise status updates

Background:

• TECLens (www.TECLens.com) 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 systems
• A photoactive drug that interacts with the UV to provide corneal strengthening that results in refractive change
• A 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 procedure

The 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.

Responsibilities:

• Manage Site Relationships serving as the primary day-to-day contact for investigators, coordinators, and site staff across all active clinical sites
• Drive Enrollment by tracking screening and enrollment metrics, identifying barriers, and working with sites to implement solutions
• Manage Site Logistics including creative solutions to supply chain and import challenges in emerging markets
• Manage Clinical Data Flow by coordinating with sites on case report form completion, query resolution, and data quality
• Track and Report Study Metrics including enrollment, visit completion, protocol deviations, and adverse events
• Coordinate Site Training for new personnel and protocol amendments
• Maintain Trial Master File ensuring essential documents are collected, reviewed, and filed in a timely manner
• Support Monitoring Activities by preparing for and following up on monitoring visits, whether conducted internally or by CRO partners

Ideal Candidate:

BS 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.

Additional Qualifications:

• Direct experience with regulatory submissions in Latin America (ANVISA, INVIMA, or similar)
• Experience with FDA IDE studies or international device trials highly desirable
• Familiarity with ophthalmic clinical trials a plus
• Working knowledge of GCP, ICH E6, and ISO 14155
• Experience with EDC systems and clinical trial management systems
• Spanish and/or Portuguese language skills desirable
• Strong English written and verbal communication skills
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, and PowerPoint
• Experience with regulatory submissions in Latin America (ANVISA, INVIMA, or similar) beneficial