Senior Clinical Trial Associate — Remote

Bausch & Lomb GmbH; Northern (KY); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Tuition reimbursement program

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to support the execution, conduct, and closeout of clinical studies in compliance with the Investigational Plan and regulatory requirements. The role involves collaboration across CTMs, clinical sites, and cross-functional teams to ensure high-quality trial conduct.

The candidate will assist with protocol development, site management, TMF documentation, and study-start activities, while maintaining strong communication and operational

Qualifications

• Bachelor’s degree in a health profession or science.
• At least 3 years of on-going clinical trials experience.
• Demonstrated proficiency in knowledge of GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to effectively work independently.
• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook).
• Travel may be required (minimal).

Responsibilities

• Collaborates and supports CTM/Sr. CTM on required tasks prior to commencement of clinical trials.
• Supports clinical operations to ensure compliance with FDA and other regulatory requirements.
• Communicates with clinical trial sites regarding conduct, monitoring, and visits.
• Assists in tracking study payments and invoices.
• Provides operational support to ensure systems and procedures are completed.
• Collaborates with R&D, Regulatory, Safety, and Quality/Compliance.
• Supports TMF and start-up activity documentation.
• Assists in presenting clinical information for specific projects.
• Works on projects requiring judgment and flexibility.

Skills

GCP knowledge

FDA regulatory knowledge

Medical terminology

Independent working

Verbal and written communication

Computer proficiency

Education

Bachelor’s degree in health or science

Advanced degree a plus

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Bausch + Lomb is seeking a Clinical Operations professional to support the execution, conduct, and closeout of clinical studies in compliance with the Investigational Plan and regulatory requirements. The role involves collaboration across CTMs, clinical sites, and cross-functional teams to ensure high-quality trial conduct.

The candidate will assist with protocol development, site management, TMF documentation, and study-start activities, while maintaining strong communication and operational