Senior Clinical Trials Operations Lead

Bausch + Lomb; San Juan (PR); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401(k) plan and company match

Tuition reimbursement program

Company holidays

Well-being benefits

Paid sick time and vacation

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to assist the Director and Sr. Clinical Trial Manager in implementing and closing out clinical studies.

The role covers protocol development, site coordination, TMF structure, regulatory submissions, and cross-functional collaboration. The candidate will support study conduct, monitoring, and administrative tasks, ensuring adherence to GCP and FDA requirements while coordinating with multiple teams and trial sites.

Qualifications

• Bachelor's degree in health profession or science; advanced degree a plus.
• At least 3 years of ongoing clinical trials experience.
• Strong knowledge of GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.

Responsibilities

• Support CTM/Sr. CTM on clinical planning, protocol and CRF development, IRB submissions, site selection and TMF prep.
• Assist in study conduct, monitoring, and close-out activities to ensure GCP compliance.
• Track study payments and invoices; provide workflow support for systems and procedures.
• Collaborate with R&D, Regulatory, Safety and Quality teams on projects.
• Prepare administrative documents for study programs, TMFs and start-up activities.
• Assist in presentations of clinical information for projects.

Skills

GCP knowledge

FDA regulatory knowledge

Communication skills

Independent work

Medical terminology

Education

Bachelor's in health science

Advanced degree a plus

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Bausch + Lomb is seeking a Clinical Operations professional to assist the Director and Sr. Clinical Trial Manager in implementing and closing out clinical studies.

The role covers protocol development, site coordination, TMF structure, regulatory submissions, and cross-functional collaboration. The candidate will support study conduct, monitoring, and administrative tasks, ensuring adherence to GCP and FDA requirements while coordinating with multiple teams and trial sites.