Site Manager

Key Responsibilities:

• Team Leadership & Management:
• Supervise and mentor clinical research staff, including investigators, coordinators, and lab personnel.
• Organize, prioritize, and schedule work assignments effectively.
• Provide direction and support during subject screening and enrollment to meet study goals.
• Develop, train, and manage team members, including recruiting, interviewing, and performance evaluations.
• Foster a positive workplace culture aligned with organizational values.

• Clinical Trials Oversight:
• Oversee all aspects of clinical trials, ensuring compliance with FDA regulations, GCP guidelines, and organizational SOPs.
• Ensure all personnel are trained on study protocols and responsibilities prior to study initiation.
• Monitor study progress and make adjustments as necessary to meet enrollment and performance targets.

• Regulatory Compliance:
• Ensure accurate and timely reporting of adverse events and serious adverse events.
• Maintain thorough documentation of drug/device distribution and accountability.
• Manage IRB submissions, vendor assessments, and regulatory compliance.

• Operational Management:
• Implement and monitor Key Performance Indicators (KPIs) to ensure high site performance.
• Oversee accurate case report forms and ensure completeness per FDA and sponsor requirements.
• Coordinate and lead staff meetings and communicate with sponsors and other stakeholders.

• Financial & Performance Metrics:
• Understand and manage financials related to clinical trials.
• Ensure effective site performance and manage site operations to maximize revenue and efficiency.

• Administrative Duties:
• Operate basic office equipment and maintain records.
• Provide timely feedback and coaching to staff, addressing performance issues and providing career development opportunities.
• Travel to investigator meetings and adapt to flexible hours as needed.

Minimum Qualifications:

• Experience: Minimum of 5 years in clinical research, with 7-10 years preferred. Strong expertise in ophthalmology and site management is highly preferred.
• Education: Bachelor’s degree in a related field required; master’s degree preferred.
• Certifications: CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within the first two weeks of hire (training provided); CCRC certification preferred.
• Skills: Excellent leadership, communication, and organizational skills. Ability to multi-task and adapt to dynamic therapeutic areas.

Additional Requirements:

• Travel: Ability to travel locally and nationally as needed.
• Location: Must be based out of the site office.
• Flexibility: Willingness to work flexible hours and take on additional tasks as needed, and able to step in as a coordinator or assist in the lab if required.

Technical Skills:

• Systems Experience: Proficiency with Electronic Data Capture systems and Clinical Trial Management Systems (CTMS) preferred.
• Software Proficiency: Skilled in Microsoft Teams, PDF Filler and DocuSign.

Physical Requirements:

• Lifting and Carrying: Ability to lift or carry up to 10 pounds.
• Pushing and Pulling: Capability to push or pull up to 10 pounds.
• Movement: Regular sitting, standing, walking, and stooping.
• Strength and Coordination: Adequate strength and coordination to handle equipment and assist patients effectively.

Salary: Commensurate with experience.