Clinical manager h1.location_city

Bausch + Lomb is a global leader in eye health, dedicated to enhancing vision and improving quality of life for individuals worldwide. With a remarkable legacy of over 170 years, we utilize our expertise and extensive product portfolio, comprising more than 400 offerings, to meet diverse eye health needs across the globe.

Role Overview:

We are looking for a passionate Clinical Trials Lead to join our Clinical Operations team. This pivotal role involves overseeing the execution of clinical studies, ensuring they meet investigational plans and regulatory standards. You will play an integral part in providing top-notch clinical and technical support across our clinical programs and marketing investigations.

Key Responsibilities:

• Lead and collaborate on pre-trial activities, including clinical planning, protocol development, and IRB submissions to set the stage for successful trials.

• Ensure all clinical trials comply with FDA and international regulatory requirements, as well as adhere to our internal standard operating procedures.

• Act as the primary contact for vendors and clinical trial sites for study conduct, monitoring, and data management, fostering clear and effective communication.

• Oversee clinical data processes in alignment with departmental SOPs, ensuring integrity and accuracy throughout.

• Review case report forms (CRFs) and generate Data Clarification Forms (DCFs) to uphold data accuracy and reliability.

• Assist in data evaluation and trial reporting, including preparation for FDA submissions and scientific manuscripts.

• Track study-specific payments and provide operational support to maintain efficient workflows.

• Collaborate with cross-functional teams for cohesive project execution and to drive shared objectives.

• Facilitate communication between internal and external stakeholders to foster cooperation and enhance project outcomes.

• Present clinical information related to specific projects to diverse audiences, ensuring clarity and engagement.

Qualifications:

• Bachelor's degree in a health profession or science; advanced degree is preferred.

• A minimum of 5 years' experience in clinical trials, showcasing a deep understanding of the industry.

• Thorough knowledge of GCPs and FDA regulatory requirements is essential.

• Familiarity with medical terminology is key to success in this role.

• Self-motivated individual with the ability to work independently and efficiently.

• Strong verbal and written communication skills along with proficiency in Word, Excel, and data management tools.

What We Offer:

• Comprehensive benefits starting from your hire date, including medical, dental, and life insurance.

• 401K plan with matching contributions to support your future.

• Generous paid time off, including vacation and sick days to promote work-life balance.

• Employee stock purchase plan and performance-based incentive bonuses as part of our commitment to you.

• Tuition reimbursement for select degrees to support your professional development.

• Regular performance feedback and annual compensation reviews to recognize your contributions.

Applicants must be authorized to work for any employer in the U.S. We currently cannot provide sponsorship for employment visas.