Central Monitor

Piper Companies is looking for a Central Monitor to join a clinical research organization (CRO) company located in Bethesda, MD.

Responsibilities of the Central Monitor include:

· Develop and maintain risk-based quality management and centralized monitoring processes, templates, and tools for corporate and trial-specific use

· Review study protocols to confirm feasibility of KRIs and QTLs setup, reporting, and standardization requirements

· Lead risk assessments for studies and recommend protocol-specific risk indicators for centralized monitoring

· Assist with configuration and validation of centralized monitoring data analysis platforms

· Analyze clinical study data to identify potential site performance or organizational issues and provide recommendations for CRA follow-up

· Train project teams on interpreting central monitoring signals and making informed decisions for study conduct

· Maintain and update operational risk logs for clinical risk management activities

· Provide guidance, mentorship, and coordination for all centralized monitoring tasks

· Monitor dashboards and outputs, suggest actions for signal management, and ensure timely resolution with study teams

· Act as the SME for central monitoring during dashboard development and implementation

· Advise clients and sponsors on best practices for centralized monitoring in a client-facing capacity

· Collaborate effectively with CRAs, Clinical Project Managers, Trial Managers, and Data Management teams

· Apply knowledge of regulatory requirements (FDA, ICH/GCP), data analysis, and statistical principles in central monitoring activities

· Support government and commercial contracts across multiple therapeutic areas, including infectious disease, oncology, and medical devices

· Report program status and potential risks to leadership and recommend mitigation strategies

· Ensure adherence to documented processes and timelines, and take corrective action to prevent delays

· Maintain accuracy and attention to detail in a fast-paced environment with shifting priorities

· Comply with Quality Management System policies and procedures

· Contribute to corporate initiatives such as SOP development, process improvement, proposal writing, and bid defense meetings

· Assist with audit preparation, inspection readiness, and post-inspection follow-up activities

Qualifications for the Central Monitor include:

· Strong understanding of ICH GCP and regulatory requirements, with emphasis on Risk-Based Quality Management and Central Monitoring

· Minimum of 3 years of experience in centralized monitoring within a CRO environment

· Previous experience as a CRA performing on-site monitoring or equivalent skill set

· Familiarity with centralized monitoring database systems and processes

· Proven ability to lead or mentor teams, develop procedures, and advise on best practices and tools for central monitoring

· Excellent facilitation, presentation, and problem-solving skills; strong written and verbal communication; attention to detail and quality control; and experience with clinical research systems and tools

· Background in infectious disease or oncology trials, or prior work on government contracts, is preferred

· Bachelor’s degree required

· COVID-19 vaccination (first and second dose) required

Compensation for Central Monitor includes:

· Rate Range: $85,000-$125,000, depending on experience

· Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on December 15, 2025. Applications will be accepted at least 30 days from the posting date.

Keywords: Central Monitoring, Risk-Based Quality Management, Clinical Trials, ICH GCP, KRIs, QTLs, Clinical Risk Management, CRO, CRA, Data Analysis, FDA Regulations, Oncology, Infectious Disease, Clinical Research, Remote, Bethesda MD

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