Clinical Program Manager, Field Monitoring

Olympus Corporation of the Americas•Upper Saucon, PA

2d•$104,061 - $145,685•Remote

About The Position

The Clinical Program Manager, Field Monitoring is responsible for the strategic oversight, development, and execution of the organization’s field monitoring program. This role serves as the functional leader for monitoring within Clinical Operations, ensuring consistent, compliant, and high-quality monitoring practices across all clinical studies. This position oversees Clinical Research Associates (CRAs), owns monitoring-related Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), and drives continuous improvement of monitoring infrastructure, performance and inspection readiness. The Clinical Program Manager, Field Monitoring reports to the Senior Manager, Clinical Operations.

Requirements

BA/BS or equivalent experience in scientific field or related healthcare disciplines.
Minimum of 8 years of clinical research experience, including significant field monitoring experience. Previous experience with medical device trials preferred.
Minimum of 2 years of people management and leadership including or demonstrated functional leadership of CRAs including coaching.
Proficient skills with MS suite of programs and windows-based applications including Excel, PowerPoint, Project, Publisher, Word, and Visio.
Deep knowledge of ICH-GCP, FDA, ISO 14155 regulatory frameworks and inspection readiness practices.
Experience developing SOPs and operational frameworks.
Demonstrated experience and competency defining and managing KPIs as well as analytical and performance management capability.
Strategic program thinking with high accountability and ownership.
Operational discipline and execution.
Excellent communication skills (oral and written).
Strong organizational skills with attention to detail.
Strong ability to build and maintain positive relationships with management and peers.
Ability to work independently and manage multiple tasks in a fast-paced environment.
Strong leadership and cross-functional collaboration skills.
Valid driver’s license.
Ability to travel domestically up to 40%.

Responsibilities

Lead the development and continuous improvement of the field monitoring program.
Establish and standardize monitoring strategies across studies.
Ensure consistent application of risk-based monitoring approaches.
Build scalable infrastructure to support organizational growth.
Author, maintain, and optimize monitoring-related SOPs, work instructions, and templates.
Ensure alignment with ICH-GCP, FDA regulations, ISO 14155, and applicable global standards.
Partner with Clinical Quality to support audit and inspection readiness.
Identify process gaps and implement corrective actions.
Oversee CRO delivered monitoring activities, including review of performance metrics, visit quality and compliance with Olympus standards, escalate performance concerns and drive corrective actions as needed.
Define and own monitoring KPIs (e.g., visit timeliness, monitoring report cycle time, issue resolution, deviation trends).
Establish performance thresholds and monitor adherence.
Identify systemic risks and performance trends.
Implement and track corrective and preventative actions.
Provide monitoring performance insights to Clinical Operations leadership.
Directly manage Clinical Research Associates (CRAs).
Lead hiring and workforce planning efforts for monitoring staff in collaboration with Clinical Operations leadership.
Conduct performance management, coaching, and professional development.
Ensure appropriate resource allocation and workload balancing.
Oversee onboarding and training of monitoring staff.
Partner with Clinical Project Managers (CPMs) to align monitoring plans with study risks.
Collaborate with Global Clinical Leaders, Data Management, Regulatory, Biostatistics, and Clinical Quality to resolve compliance or monitoring-related issues.
Serve as the subject matter expert for field monitoring processes.
Support inspection readiness activities and represent monitoring during audits as needed.
Other responsibilities as assigned