Global Clinical Operations Lead for Multi-Site Trials

TECLens; Stamford (CT); Hybrid; USD 100,000 - 150,000; Full time

Job summary

TECLens, a Stamford, CT-based medical technology company, seeks a hands-on Clinical Operations Manager to lead international trials. You will own site relationships, enrollment management, regulatory submissions, and operational support across active sites in the Philippines, Dominican Republic, and Brazil.

The ideal candidate holds a BS in Life Sciences/Engineering or a related field with 5+ years of clinical operations experience in medical device or pharmaceutical trials, including

Qualifications

• 5+ years of clinical operations experience in medical device or pharmaceutical trials.
• Experience managing multi-site US and international studies.
• Familiarity with regulatory submissions in LATAM (ANVISA, INVIMA) and FDA IDE projects.

Responsibilities

• Manage site relationships with investigators, coordinators, and site staff across active sites.
• Drive enrollment by tracking screening and enrollment metrics and addressing barriers.
• Coordinate regulatory submissions and ensure timely filings.
• Maintain Trial Master File and essential study documents.
• Support monitoring activities with CROs or internal teams.

Skills

Clinical operations

Regulatory submissions

Site management

Data management

Communication skills

Education

BS in Life Sciences/Engineering, Nursing, Optometry or related field

Tools

EDC systems

Clinical trial management systems

Job description

TECLens, a Stamford, CT-based medical technology company, seeks a hands-on Clinical Operations Manager to lead international trials. You will own site relationships, enrollment management, regulatory submissions, and operational support across active sites in the Philippines, Dominican Republic, and Brazil.

The ideal candidate holds a BS in Life Sciences/Engineering or a related field with 5+ years of clinical operations experience in medical device or pharmaceutical trials, including