Senior Clinical Trials Operations Specialist

Bausch + Lomb; Lincoln (NE); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement

Job summary

Bausch + Lomb is seeking a Sr. Clinical Trial Manager to support the planning, conduct, and closeout of clinical studies. You will work under the Director of Clinical Operations, ensuring trials meet ICH/GCP standards and FDA requirements, while coordinating with sites and internal teams.

The role emphasizes collaboration across Regulatory, Safety, and Quality/Compliance, with potential travel and a focus on operational excellence in study management.

Qualifications

• Bachelor's degree in a health profession or science; advanced degree a plus.
• At least 3 years of ongoing 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; computer proficiency (Word, Excel, Outlook).

Responsibilities

• Collaborates with CTM/Sr. CTM on tasks prior to commencement of clinical trials: protocol development, CRF development, IRB submissions, ICF development, site selection, TMF structure, and site communications.
• Supports regulatory compliance with FDA and other international requirements and SOPs during all investigations and studies.
• Communicates with clinical trial sites regarding conduct, monitoring, logistics, follow-up, and close-out visits.
• Assists in tracking study payments and invoices.
• Provides operational support to ensure cross-functional systems run efficiently.
• Collaborates on project teams with R&D, Regulatory, Safety, and Quality/Compliance.
• Assists with administrative documents related to TMFs and start-up activities.
• Supports presentations of clinical information for specific projects.
• Works on moderately to highly complex projects requiring judgment and flexibility.

Skills

GCP knowledge

FDA regulatory knowledge

Verbal & written communication

Independent work

Computer proficiency

Travel readiness

Education

Bachelor's degree in health profession or science

Job description

Bausch + Lomb is seeking a Sr. Clinical Trial Manager to support the planning, conduct, and closeout of clinical studies. You will work under the Director of Clinical Operations, ensuring trials meet ICH/GCP standards and FDA requirements, while coordinating with sites and internal teams.

The role emphasizes collaboration across Regulatory, Safety, and Quality/Compliance, with potential travel and a focus on operational excellence in study management.