Senior Clinical Site Manager

About the role

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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Ensure compliance with ICH-GCP, FDA regulations, ISO 1