Clinical Site Manager - Western US

Employment Type: Full-time

Position Overview

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

The Clinical Site Manager is responsible for overseeing clinical trial activities at designated investigational sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. The Clinical Site Manager serves as the primary point of contact between Alcon and the clinical sites, fostering effective communication and ensuring successful execution of clinical trials that align with organizational goals.

Responsibilities

Site Oversight and Relationship Management

• Serve as the primary liaison between Alcon and assigned clinical sites.
• Build and maintain strong relationships with site staff, investigators, and key stakeholders.
• Facitate effective communication and address site-specific concerns or challenges promptly.
• Actively engage with the Clinical Operations Lead (COL) and other Clinical Trial Team members to identify and resolve site quality or study execution issues.

Clinical Trial Management

• Support site evaluation, and oversee site activation/initiation, monitoring, and close-out activities.
• Ensure clinical trial protocols, study-specific procedures, and GCP standards are adhered to at all times.
• Conduct site visits (both remote and on-site) to monitor study progress, identify issues, and ensure timely data collection in accordance with the study-specific monitoring plan and relevant SOPs/Job Aids.

Regulatory and Compliance Support

• Ensure sites comply with regulatory requirements, including IRB/IEC submissions and approvals.
• Assist in resolving compliance issues and ensure corrective and preventive actions are implemented effectively.

Training and Support

• Provide ongoing training and guidance to site staff regarding protocol requirements, electronic data capture (EDC) systems, and other study tools.
• Support sites in resolving operational challenges, such as patient recruitment and retention strategies.
• Onboarding/Mentoring new hires for the department including co-monitoring visits.
• Improving departmental efficiencies by leading/participating on Process Improvement Teams.

Data Integrity and Quality

• Review and monitor source documents and case report forms to ensure data accuracy and completeness.
• Work with the data management team to resolve queries and discrepancies in a timely manner.

Requirements

Experience

• Bachelor’s degree in a scientific, medical, or related field (Master’s degree preferred).
• 4 years of experience in clinical trial management, site monitoring, or a related role.
• Strong understanding of GCP, ICH guidelines, and applicable regulatory requirements.
• Experience with ophthalmology or medical device trials is highly preferred.

Skills and Competencies

• Excellent interpersonal and communication skills to build and maintain site relationships.
• Strong organizational and multitasking abilities to manage multiple sites and studies simultaneously.
• Analytical and problem-solving skills to identify and address issues proactively.
• Proficiency in clinical trial management systems (CTMS), eTMF, EDC platforms, and Microsoft Office Suite.
• Ability to work independently and collaboratively in a fast-paced environment.

Physical Demands

• Ability to sit, stand, and walk for extended periods of time during site visits and monitoring activities.
• Must have the ability to lift and carry up to 25 pounds (e.g., clinical materials, equipment).
• Prolonged periods of working on a computer and reviewing electronic and paper documents.

Company Information

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.