Senior Clinical Trial Associate
About The Position
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.
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).
Nice To Haves
- Advanced degree a plus.
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 payments and 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
Benefits
- medical, dental, vision insurance
- disability and life insurance
- a 401(k) plan and company match
- a tuition reimbursement program (select degrees)
- company holidays
- well-being benefits
- sick time
- floating holidays
- paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
