Sr. Clinical Trials Associate II

About the role

The Sr. Clinical Trials Associate II plays a crucial role in the advanced coordination and execution of clinical research studies, ensuring compliance with U.S. and international regulatory requirements.

Responsibilities

• Serve as a core contributor to the development and refinement of clinical trial protocols and study documentation
• Lead coordination of clinical study activities across multiple sites and stakeholders
• Provide subject matter expertise to improve study execution and operational processes
• Independently manage site communications and ensure alignment with study timelines and objectives
• Deliver advanced analysis and interpretation of study data to support decision-making
• Perform in-depth review and analysis of complex clinical data from investigative sites
• Identify systemic data trends, risks, and discrepancies; recommend and implement corrective actions
• Lead data cleaning efforts and ensure data integrity across assigned studies
• Provide guidance to junior team members on data review processes and best practices
• Oversee the establishment, maintenance, and continuous improvement of Study Master Files
• Ensure completeness, quality, and audit readiness of all study documentation
• Implement process improvements to enhance document control and tracking efficiency
• Provide leadership-level reporting on SMF status, risks, and compliance
• Collection and quality review of site start-up documentation
• Drive resolution of site documentation issues and ensure regulatory compliance
• Partner with CRAs to ensure readiness for monitoring visits and audits
• Analyze tracking data to identify operational risks and recommend solutions
• Lead internal and external meetings, including investigator site interactions
• Provide mentorship and guidance to less experienced CTAs
• Perform co-monitoring activities and support CRA development
• Contribute to continuous improvement initiatives across clinical operations

Requirements

• 8+ years of experience as a Clinical Trials Associate, preferably within the ophthalmic field
• Demonstrated advanced expertise in clinical trial execution, including study start-up, conduct, and close-out
• Strong working knowledge of GCP, FDA, and international regulatory requirements
• Proven ability to independently manage multiple studies or complex components of larger programs
• Demonstrated experience leading data review, data cleaning, and issue resolution activities
• Expertise in Study Master File management and audit/inspection readiness
• Ability to identify process gaps and proactively implement improvements
• Experience leading meetings, influencing stakeholders, and mentoring junior staff
• May serve as a subject matter expert in systems, processes, or regulatory areas
• Strong analytical, organizational, and problem-solving skills with the ability to work with minimal supervision