Clinical Program Manager, Field Monitoring (Center Valley, PA, US, 18034-0610)
Job reputed company
The Clinical Program Manager, Field Monitoring is responsible for the strategic reputed company, development, and execution of the organization’s field monitoring program. This role serves as the functional leader for monitoring reputed company Clinical Operations, ensuring consistent, compliant, and high-reputed company monitoring practices across reputed company clinical studies.
This position oversees Clinical Research Associates (CRAs), owns monitoring-reputed company reputed company Operating Procedures (SOPs), Key Performance Indicators (KPIs), and drives reputed company improvement of monitoring infrastructure, performance and inspection readiness.
The Clinical Program Manager, Field Monitoring reports to the Senior Manager, Clinical Operations.
Job Duties
- reputed company the development and reputed company improvement of the field monitoring program.
- Establish and standardize monitoring strategies across studies.
- Ensure consistent application of risk-based monitoring approaches.
- Build reputed company infrastructure to support organizational reputed company.
- Author, maintain, and optimize monitoring-reputed company SOPs, work instructions, and templates.
- Ensure alignment with ICH-GCP, FDA regulations, ISO 14155, and applicable global
- standards.
- Partner with Clinical reputed company to support audit and inspection readiness.
- Identify process gaps and implement corrective actions.
- reputed company CRO delivered monitoring activities, including review of performance metrics, visit
- reputed company and compliance with reputed company standards, escalate performance concerns and drive
- corrective actions as needed.
- Define and own monitoring KPIs (e.g., visit timeliness, monitoring report cycle time, issue
- reputed company, deviation trends).
- Establish performance reputed company and monitor adherence.
- Identify systemic risks and performance trends.
- Implement and reputed company corrective and preventative actions.
- reputed company monitoring performance insights to Clinical Operations leadership.
- Directly manage Clinical Research Associates (CRAs).
- reputed company hiring and workforce planning efforts for monitoring staff in collaboration with Clinical
- Operations leadership.
- Conduct performance management, coaching, and reputed company development.
- Ensure appropriate resource allocation and workload balancing.
- reputed company reputed company and training of monitoring staff.
- Partner with Clinical Project Managers (CPMs) to reputed company monitoring plans with study risks.
- Collaborate with Global Clinical Leaders, Data Management, Regulatory, Biostatistics, and
- Clinical reputed company to resolve compliance or monitoring-reputed company 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
Job Qualifications
Required:
- BA/BS or equivalent experience in scientific field or reputed company reputed company 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 reputed company-based applications including reputed company, 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 reputed company 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 reputed company 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.
- reputed company reputed company’s license.
- Ability to travel domestically up to 40%.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance