Manager, Clinical Trials (Ophthalmology)
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Job details
Pay: $100,000 - $140,000 a year
Benefits:
- 401(k) matching
- Disability insurance
- Employee stock purchase plan
- Life insurance
- Paid time off
Full 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.
Key Activities/Responsibilities:
- Leads or collaborates on required tasks prior to commencement of clinical trials including clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, and communication with clinical trial sites regarding all logistics including contract agreements, support materials, and training.
- Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs).
- Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, and logistical management of follow-up and close out study visits.
- Collaborates on clinical data processing in accordance with departmental SOPs and guidelines.
- Verifies, reviews, and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data.
- Assists in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements.
- Assists in tracking study specific payments.
- Provides operational or workflow support to assure that departmental and cross-functional systems and procedures are efficiently completed.
- Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality/Compliance.
- Leads or collaborates on technical writing projects including white papers, abstracts, manuscripts, and literature reviews.
- Liaison between internal and external stakeholders to facilitate cooperation.
- Conducts presentations of clinical information concerning specific projects.
- Works on projects of moderate-to-high degree of difficulty requiring analysis of identifiable clinical factors.
Requirements:
- Bachelor’s degree in a health profession or science.
- Minimum 5 years of ongoing clinical trials experience in the pharmaceutical or device industry.
- 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) and data management experience.
- 10%-30% travel required.
Language and Verbal Skills:
Individual must have good verbal and written skills plus a demonstrated ability to communicate clearly and professionally.
Analytical and Reading Skills:
Ability to read, analyze, interpret, and assist in the creation and refinement of company procedures.
We offer competitive salary & excellent benefits including:
- Medical, Dental, Eye Health, Disability, and Life Insurance begins on your hire date.
- 401K Plan with company match and ongoing company contribution.
- Paid time off – vacation (3 weeks - prorated upon hire), floating holidays, and sick time.
- Employee Stock Purchase Plan with company match.
- Employee Incentive Bonus.
- Tuition Reimbursement (select degrees).
- Ongoing performance feedback and annual compensation review.
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.
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