Bausch + Lomb France · 4 hours ago
Manager, Clinical Trials
United States
Full-time
Remote
Mid, Senior Level
$100K/yr - $150K/yr
5+ years expBausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world. The Manager, Clinical Trials is responsible for overseeing the implementation of clinical studies, ensuring compliance with regulations, and providing clinical and technical expertise for Clinical Programs and Marketing Investigations.
Medical Device
No H1B
U.S. Citizen Only
Responsibilities
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
Qualification
Required
Bachelor's degree in a health profession or science
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
Preferred
Advanced degree preferred
Benefits
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
Company
Bausch + Lomb France
Bausch+Lomb, c’est avant tout un laboratoire dédié à la protection et à l’amélioration de la vue de millions de personnes dans le monde, pour les accompagner dès leur naissance et à chaque phase de leur vie.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase