[Remote] Senior Clinical Site Manager Job Details | Olympus Corporation of the Americas

Note: The job is a remote job and is open to candidates in USA. Olympus is hiring a Senior Clinical Site Manager to provide strategic and operational oversight of clinical trial sites. The role leads site relationships, enrollment and retention strategies, performance monitoring, risk mitigation, and compliance across study execution.

Responsibilities

• 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

Skills

• 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
• 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

Benefits

• Annual bonus (subject to plan eligibility and other requirements)
• 401(k) with company match (US Only)
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance (US Only)
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center (Center Valley, PA and Westborough, MA)
• Work-life integrated culture that supports an employee centric mindset
• Onsite, hybrid and field work environments
• Remote workplace flexibility; working location is nationwide
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

Company Overview