Clinical Operations Manager

Job Description

This role is responsible for managing a clinical team and supporting the day-to-day activities associated with the execution and monitoring and trials and support of clinical procedures. This position ensures that clinical tasks and procedures are being performed in compliance with applicable regulatory standards, ICH-GCP Guidelines, and all applicable regulatory requirements and company policies and procedures.

Job Duties

• Oversees and manages a clinical team of Clinical Site Managers (CSM), Clinical Research Associates (CRA), Clinical Trial Coordinators (CTC) and/or contingent employees to ensure successful execution of clinical trials and projects.
• Ensures activities related to site qualification, IRB submission, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) are performed in compliance with the study-specific Clinical Monitoring Plan, Standard Operating Procedures, GCP, and applicable government regulations and guidelines.
• Responsible for monitoring and trial coordination oversight including the development of monitoring schedules, key performance indicators, and status reports.
• Participates in developing clinical study monitoring strategy and plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.
• Provides regular updates of study progression; proactively identifies and resolves issues that arise during study conduct; manages escalation of study-related issues to the Clinical Project Manager and/or the Global Lead.
• Assists in the development of appropriate standard operating procedures (SOP) and work instructions (WI) to ensure compliance with ICH-GCP guidelines and company SOPs/WIs for clinical studies.
• Creates and conducts training sessions, including investigator meetings and site training.
• Participates in study audits, as applicable, including providing guidance at the site and project levels towards audit readiness standards and supporting preparation for audit and required follow-up action.
• Coordinates with Regulatory and Medical Safety for tracking and monitoring the reporting of Adverse Events, including conducting risk assessments/mitigation and contingency planning if required.
• Provides technical and procedure support to clinical investigators and site coordinators regarding device use per IFU and trial information.
• Assists the Clinical Project Manager (CPM) with tracking the progress of clinical study enrollment, milestones, and deliverables.
• Acts as primary liaison with study site personnel and ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsors face-to-face meetings.
• Coordinates with data management on EDC build, UAT, and other data management activities.
• Maintains excellent rapport with internal and external customers to accomplish Olympus’s clinical trial goals. Serves as a key contact and advisor between the Company, CROs, clinical sites, other clinical staff and consultants to the company. 
• Takes ownership of the Clinical Affairs mission, and objectives. 
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field is a must.
• Minimum 5+ years of device/pharmaceutical industry experience in Clinical Affairs/Operations.
• Minimum 3+ years of direct experience with on-site monitoring.
• Minimum 1+ year of people management experience required. 
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Domestic and international travel up to 20%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
• Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings. 

Preferred:

• Strong budget and forecasting expertise. Experience with clinical trial agreement negotiation preferred.
• Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of regional regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.