Manager, Clinical Trials (Ophthalmology)

$100,000 - $140,000/Yr

Bausch Health - Charleston, WV

Full-time - Mid Level

Charleston, WV

10,001+ employees

Chemical Manufacturing

About the position

Bausch + Lomb is seeking a Manager for Clinical Trials in Ophthalmology to lead and oversee clinical trial activities. This role is pivotal in ensuring that clinical trials are conducted in compliance with FDA regulations and company standard operating procedures. The Manager will be responsible for a variety of tasks prior to the commencement of clinical trials, including clinical planning, protocol development, and site selection. They will also manage communication with clinical trial sites regarding logistics, contract agreements, and training materials. In addition to overseeing the clinical trials, the Manager will provide clinical oversight to ensure compliance with Good Clinical Practices (GCP) and other regulatory requirements. This includes monitoring study conduct, data management, and ensuring that all necessary documentation is completed accurately. The Manager will also collaborate with various departments, including Clinical Operations, Research and Development, and Regulatory Affairs, to facilitate the smooth execution of clinical trials. The role requires strong analytical skills to evaluate and analyze clinical trial data, assist in report writing, and ensure that all data is accurately captured and reported. The Manager will also be involved in technical writing projects, including white papers and manuscripts, and will serve as a liaison between internal and external stakeholders. This position is essential for maintaining the integrity of clinical data and ensuring that Bausch + Lomb continues to lead in the advancement of eye health.

Responsibilities

• Leads or collaborates on required tasks prior to commencement of clinical trials including clinical planning, protocol development, and IRB submissions.
• Provides clinical oversight and management for clinical trials to ensure compliance with FDA and international regulatory requirements.
• Communicates with vendors and clinical trial sites regarding study conduct and logistical management.
• Collaborates on clinical data processing in accordance with departmental SOPs and guidelines.
• Verifies, reviews, and tracks CRFs and generates Data Clarification Forms for missing or inaccurate data.
• Assists in the evaluation and analysis of clinical trial data for reporting requirements.
• Assists in tracking study specific payments.
• Provides operational or workflow support to ensure efficient completion of departmental systems and procedures.
• Collaborates on project teams with Clinical Operations, Research and Development, Safety, and other departments.
• Leads or collaborates on technical writing projects including white papers and manuscripts.
• Acts as a liaison between internal and external stakeholders to facilitate cooperation.
• Conducts presentations of clinical information concerning specific projects.
• Works on projects of moderate-to-high difficulty requiring analysis of 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, with preference for both.
• Demonstrated proficiency in knowledge of GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to work independently and effectively.
• Excellent verbal and written communication skills, along with computer proficiency (Word, Excel, Outlook) and data management experience.

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