Senior Clinical Site Manager

Job Description

This role is responsible for the strategic and operational oversight of clinical trial activities at clinical study sites, ensuring high-quality execution, compliance, and achievement of enrollment goals.

This role serves as the primary liaison between Olympus and clinical trial sites, with a strong emphasis on proactive site engagement, communication, and performance optimization. This position leads site relationship management, drives enrollment acceleration strategies, and partners cross-functionally to identify risks and implement mitigation plans.

This role is expected to operate with a high degree of autonomy and provide leadership in site management, recruitment strategy development, and study execution, while acting as a key contributor to study success.

Job Duties

• Serve as the primary point of contact and relationship owner for assigned clinical trial sites, establishing strong partnerships with investigators and site personnel through proactive communication, routine engagement, and ongoing site support.
• Lead the operational oversight of assigned clinical trial sites from qualification through close-out, including feasibility assessments, site selection, activation activities, site training, compliance oversight, and maintenance of inspection readiness.
• Develop, implement, and oversee site-specific enrollment and retention strategies, partnering with investigative sites to identify barriers, drive recruitment initiatives, share best practices, and ensure achievement of enrollment targets.
• Monitor, analyze, and report study and site performance metrics, including site activation, screening, enrollment, retention, protocol compliance, and data quality, implementing corrective and preventive actions when necessary.
• Collaborate with Data Management and investigative sites to ensure timely and accurate data entry, query resolution, eCRF completion, and overall data integrity.
• Identify, assess, and mitigate risks that may impact enrollment, timelines, data quality, patient safety, or study execution, escalating critical issues and providing clear recommendations to management and study teams.
• Partner with Clinical Project Managers and cross-functional stakeholders to support study planning, execution, performance reviews, continuous improvement initiatives, and the development of study documents, materials, and operational strategies.
• Ensure compliance with ICH-GCP, FDA regulations, ISO 14155, study protocols, and company SOPs through ongoing site oversight, documentation review, CTMS management, and maintenance of essential study records.
• Support quality and inspection-readiness activities by collaborating with Clinical Quality Assurance, participating in audit preparation and follow-up activities, and ensuring sites maintain adequate training records and study documentation.
• Serve as a subject matter expert in site management and enrollment optimization by providing mentorship, onboarding support, training, and guidance to junior team members and study staff.

Job Qualfications

Required:

• BA/BS or equivalent experience required in scientific field or related healthcare disciplines.
• Minimum of 6 years of clinical research experience, including significant field monitoring experience.
• Deep knowledge of ICH-GCP, FDA, ISO 14155 regulatory frameworks and inspection readiness practices.
• Demonstrated ability to build and maintain strong site relationships and influence site performance.
• Proven experience driving site engagement, enrollment strategies, and study execution.
• Experience developing SOPs and operational frameworks.
• Demonstrated experience and competency defining and managing KPIs as well as analytical and site performance management capability.
• Excellent communication skills with the ability to effectively engage sites and cross-functional teams.
• Strong analytical and problem-solving skills with the ability to identify risks and implement solutions.
• Ability to work independently and lead initiatives in a fast-paced, cross-functional environment.
• Proficient skills with MS suite of programs and windows-based applications including Excel, PowerPoint, Project, Publisher, Word, and Visio.
• Strong ability to build and maintain positive relationships with management and peers.
• Strong leadership and cross-functional collaboration skills.
• Valid driver’s license required.
• Ability to travel domestically up to 40%.

Preferred:

• Certifications (e.g., ACRP, SOCRA) preferred.
• Experience in medical device clinical trials preferred.
• Experience leading or mentoring team members preferred.
• Significant experience in site management, enrollment optimization, and cross-functional collaboration preferred.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Olympus Corporation of the Americas is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. This job description is intended to summarize the primary responsibilities and qualifications for this position. The job description is not intended as inclusive of all duties an induvial in this position might be asked to perform or of all qualifications that may be required either now or in the future.