Senior Clinical Trial Associate

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 (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives:

Under the supervision of the Director, Clinical Operations / Sr. Clinical Trial Manager, responsible for supporting the implementation, conduct and closeout of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations.

Responsibilities:

• Collaborates and supports CTM/Sr. CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training
• Supports CTM/Sr. CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies
• Supports CTM/Sr. CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
• Assists in tracking study specific paymentsand invoices
• Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
• Collaborates on project teams, primarily with Research and Development, Regulatory, Safety, and Quality/Compliance
• Supports CTM/Sr. CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
• Assists and supports CTM/Sr. CTM and clinical operations team in presentations of clinical information concerning specific projects
• Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised

Requirements:

• Bachelor’s degree in a health profession or science. Advanced degree a plus.
• At least 3 years of on-going clinical trials experience.
• Demonstrated proficiency in knowledge of GCPs and knowledge of 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).

This position may be available in the following location(s): US - Remote

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $85,000.00 and $115,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.