Senior Manager/Associate Director, Clinical Monitoring Oversight

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Lead and manage clinical monitoring operations for one or more global clinical trials.

• Ensure adherence to study protocols, Good Clinical Practice (GCP), ICH guidelines, relevant regulations, and company Standard Operating Procedures (SOPs).

• Design and execute global monitoring strategies, monitoring plans, and risk-based monitoring methodologies.

• Provide matrix oversight of internal Clinical Research Associates (CRAs) and/or Contract Research Organization (CRO) monitoring teams across various countries and regions.

• Review and authorize site initiation, routine monitoring, and close-out visit documentation.

• Evaluate monitoring performance, findings, action items, and associated follow-up activities.

• Supervise source data verification, source data review, and centralized/remote monitoring efforts.

• Identify, escalate, and address site performance challenges, protocol deviations, and data quality trends.

• Collaborate on site selection, feasibility assessments, and activation timelines.

• Manage relationships and deliverables with CROs and monitoring vendors.

• Conduct co-monitoring and oversight visits to evaluate CRA performance.

• Assist with site and vendor audits and inspections; ensure prompt resolution of findings and Corrective and Preventive Actions (CAPAs).

• Maintain inspection readiness of the Trial Master File and associated monitoring documentation.

• Track and report essential risk indicators and quality metrics.

• Contribute to the development of monitoring-related SOPs, tools, and training resources.

• Engage in the recruitment, onboarding, training, and performance evaluation of CRA staff and/or vendor teams.

• Provide therapeutic-area and protocol-specific training to CRAs and site personnel.

• Represent monitoring/site management perspectives within cross-functional study teams.

• Prepare and deliver updates on monitoring activities, enrollment patterns, and site performance metrics.

• Contribute to the development of study protocols, review of informed consent documents, and initiation of study activities.

• Assist with monitoring budget and resource forecasting, including CRA staffing and travel logistics.

⛳️ Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline required; advanced degree is an advantage.

• A minimum of 7–10 years of clinical research experience, including substantial on-site or remote monitoring experience.

• A background as a CRA/Senior CRA is highly preferred.

• Typically, a minimum of 3 years in a lead CRA, monitoring management, or a similar oversight role for Associate Director (AD)-level positions.

• Experience managing or supervising CRA teams and/or CRO monitoring vendors in global or multi-regional trials.

• Strong understanding of ICH-GCP, FDA, EMA, and other relevant global regulatory requirements.

• Familiarity with risk-based monitoring (RBM) techniques and centralized monitoring tools.

• Proven track record of ensuring data quality, patient safety, and inspection readiness across clinical trial sites.

• Exceptional leadership, communication, negotiation, and analytical skills.

• Willingness and capability to travel domestically and internationally as necessary.

• Experience across various therapeutic areas and trial phases (Phase I–IV) in drug, combination product, and/or device clinical trials is preferred.

• Direct experience in managing distributed, global teams is preferred.

• Familiarity with electronic data capture (EDC), electronic Trial Master File (eTMF), and clinical trial management systems (CTMS) is preferred.

• Experience supporting regulatory inspections (FDA, EMA, MHRA, PMDA, etc.) is preferred.

• Project management certification (PMP) or clinical research certification (CCRA, ACRP, SOCRA) is a plus.

🏝️ Benefits

• Comprehensive health insurance with FULL premium coverage.

• 401K plan with company matching contributions.

• Employee Stock Purchase Program (ESPP).

• Competitive paid time off (PTO).

• Company-paid short and long-term disability insurance.

• Company-paid life insurance.

• Flexible remote or field-based work arrangements.

• Occasional evening or weekend availability to support global teams across different time zones.