Senior Manager, Clinical Operations

Job Description

The Senior Manager, Clinical Operations 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. The Sr. Manager of Clinical Operations 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

• Oversee and manage a clinical team of Clinical Field Specialists (CFS), Clinical Research Associates (CRA), Clinical Trial Coordinators (CTC) and/or contingent employees to ensure successful execution of complex, global clinical trials and projects.
• In collaboration with cross-functional colleagues and the Senior Director, Clinical Operations, defines and drives operational strategy and study design input.
• 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.
• Participate 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.
• Create and conduct 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.
• Act 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.
• Coordinate with data management on EDC build, UAT, and other data management activities.
• Maintain 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. 
• Provides leadership, career development, coaching, and mentoring to direct reports, as well as developing a succession plan.
• As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Senior Director, Clinical Operations. 
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field.
• Minimum of 10 years device/pharmaceutical industry experience in Clinical Affairs/Operations.
• Minimum of 3 years of direct experience with on-site monitoring.
• Direct people management experience and managing teams. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
• Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• 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.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
• Domestic and international travel up to 25%, 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:

• Medical training or equivalent experience.
• Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP).
• Strong budget and forecasting expertise. Experience with clinical trial agreement negotiation preferred.