Manager, Clinical Trials (Ophthalmology)

$100,000 - $140,000/Yr

Bausch Health - Des Moines, IA

Full-time - Mid Level

Des Moines, IA

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, managing data collection, and ensuring that all clinical trial data is accurately captured and reported. The Manager will also assist in the evaluation and analysis of clinical trial data, contributing to the completion of reporting requirements and submissions to regulatory bodies. The role requires collaboration with various internal teams, including Clinical Operations, Research and Development, and Regulatory Affairs, to ensure that all aspects of the clinical trials are executed efficiently. The Manager will also be involved in technical writing projects, such as white papers and manuscripts, and will serve as a liaison between internal and external stakeholders. This position requires strong analytical skills, the ability to interpret medical literature, and excellent communication skills to present clinical information effectively.

Responsibilities

• Leads or collaborates on required tasks prior to commencement of clinical trials including clinical planning, protocol development, and site selection.
• 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 departmental systems are efficiently completed.
• Collaborates on project teams with Clinical Operations, Research and Development, 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.
• 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.

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