Manager, Clinical Trials (Ophthalmology)

$100,000 - $140,000/Yr

Bausch Health - Annapolis, MD

Full-time - Mid Level

Annapolis, MD

10,001+ employees

Chemical Manufacturing

About the position

Bausch + Lomb is seeking a Manager for Clinical Trials in Ophthalmology to lead and collaborate on various tasks essential for the successful commencement and execution of clinical trials. This role involves significant responsibilities including clinical planning, protocol development, and communication with clinical trial sites. The Manager will oversee compliance with FDA regulations and company standard operating procedures during all clinical investigations and post-market studies. This position requires effective communication with vendors and clinical trial sites to ensure adherence to protocols and Good Clinical Practice (GCP) requirements. The Manager will also be responsible for the verification and tracking of case report forms (CRFs), generating Data Clarification Forms (DCFs) for any missing or inaccurate data, and ensuring that all data changes are accurately captured in the database. Additionally, the role includes assisting in the evaluation and analysis of clinical trial data, which is crucial for meeting reporting requirements, including report writing and submissions to the FDA and scientific journals. Collaboration is key in this position, as the Manager will work closely with various teams including Clinical Operations, Research and Development, Safety, and Marketing. The role also involves leading technical writing projects such as white papers and manuscripts, and presenting clinical information to stakeholders. The ideal candidate will have a strong background in clinical trials, excellent communication skills, and the ability to work independently while managing multiple projects of moderate to high complexity.

Responsibilities

• Leads or collaborates on tasks prior to commencement of clinical trials including clinical planning and protocol development.
• 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 (DCFs) for missing or inaccurate data.
• Assists in the evaluation and analysis of clinical trial data for reporting requirements.
• Tracks study specific payments and provides operational support for departmental systems.
• 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.

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 work independently and effectively.
• Excellent verbal and written communication skills, plus computer proficiency (Word, Excel, Outlook).
• 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