Manager, Clinical Trials

Clinical Study Manager

Bausch + Lomb 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.

Objective

Under the supervision of the Director or designee of Clinical Operations, responsible for overseeing the implementation of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations. Provide clinical and technical expertise for Clinical Programs and Marketing Investigations, including on-site support.

Key Activities

Leads or collaborates 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 and communication with senior 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) during all company clinical investigations and post-market studies.

Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements.

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; ensures that data changes are correctly implemented and captured in the database or data system.

Assists in the evaluation and analysis of clinical trial data to facilitate the completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions.

Assists in tracking study-specific payments.

Provides operational or workflow support to ensure that departmental and cross-functional systems and procedures are efficiently and correctly completed.

Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality / Compliance.

Liaising between internal and external stakeholders to facilitate cooperation of others.

Conducts presentations of clinical information concerning specific projects.

Requirements

Bachelors degree in a health profession or science. Advanced degree preferred.

5 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, computer proficiency (Word, Excel, Outlook), and data management experience.

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.

This position may be available in the following location(s) : [[location_obj]] 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.