Clinical Trials Operations Lead

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

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Tuition reimbursement

Paid holidays

Paid vacation

Well-being benefits

Job summary

Bausch + Lomb in the United States is seeking a Clinical Operations support professional under the supervision of the Director, Clinical Operations / Sr. Clinical Trial Manager to assist in the implementation, conduct and closeout of clinical studies, ensuring alignment with the Investigational Plan and applicable regulations.

The role collaborates with CTM/Sr. CTM and operations teams on protocol development, site management, IRB submissions, TMF readiness, and regulatory compliance, while

Qualifications

• Bachelor's degree in health profession or science required; advanced degree a plus.
• At least 3 years of clinical trials experience.
• Demonstrated proficiency in GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to work independently.
• Excellent verbal and written communication skills; computer proficiency.

Responsibilities

• Collaborates with CTM/Sr. CTM on tasks prior to trial commencement: planning, protocol development, CRF, IRB submissions, ICF, site selection, TMF structure and training materials.
• Ensures compliance with FDA regulations and SOPs during investigations and post-market studies.
• Communicates with sites regarding study conduct, monitoring and visit management to ensure protocol and GCP adherence.
• Assists in tracking study payments and invoices.
• Provides operational support to ensure efficient cross-functional processes.
• Collaborates with R&D, Regulatory, Safety and Quality/Compliance teams.

Skills

GCP knowledge

FDA regulatory knowledge

Medical terminology

Independent work

Verbal & written communication

Computer proficiency

Education

Bachelor's degree in health profession or science

Advanced degree a plus

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Bausch + Lomb in the United States is seeking a Clinical Operations support professional under the supervision of the Director, Clinical Operations / Sr. Clinical Trial Manager to assist in the implementation, conduct and closeout of clinical studies, ensuring alignment with the Investigational Plan and applicable regulations.

The role collaborates with CTM/Sr. CTM and operations teams on protocol development, site management, IRB submissions, TMF readiness, and regulatory compliance, while