Senior Manager, Clinical Monitoring Oversight

Overview

The Senior Manager will be responsible for the overall oversight of clinical studies, ensuring the quality and integrity of risk-based monitoring deliverables. This involves developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities. The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring.

Additionally, the Senior Manager will contribute to process excellence by maintaining and continually improving standard operating procedures related to clinical monitoring, Risk-Based Quality Management, and clinical trial oversight. This includes reviewing and collaborating on the development of study plans that define risk-based monitoring strategies and tasks necessary for overseeing critical study data and processes. The role requires presenting QCO roles and procedures to study teams and CROs, training CROs on QCO expectations, and overseeing and evaluating monitoring deliverables such as Monitor Visit Reports, CTMS data, essential documents, and critical system reports.

The Senior Manager will actively participate in study team teleconferences with CRO/vendors, conduct site visits, present findings, serve as the point of contact for CROs regarding QCO activities, and provide guidance on issue resolution. Consultation with CTMs and CROs to create action plans based on QCO findings to improve monitoring quality is also a key responsibility. Furthermore, the role includes overseeing CRAs, monitoring activities, and performing management tasks such as MVR reviews, accompanied visits, and CRA teleconferences.

Close collaboration with cross-functional study team members and critical business partners is essential to implement day-to-day oversight activities while serving as a subject matter expert. The Senior Manager will perform gap assessments for internal and external SOPs/processes, identify areas for process improvement in line with current guidance and global regulations, leverage lessons learned to enhance procedures, and develop related tools, templates, and training materials. Leading training activities for QCO representatives, CRAs, and cross-functional study team members is also part of the job scope.

Responsibilities

Performance Responsibilities

• Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g., clinical monitoring plan, centralized monitoring plan, protocol deviation management plan, and integrated quality risk management plan).
• Present QCO role and procedures to study team and CRO and train the CRO on the expectations for QCO activities.
• Oversee and evaluate monitoring deliverables/outputs including review of Monitor Visit Reports and related CTMS data, eTMF/ISF essential documents, data capture (e.g., EDC, eCOA) and related queries, critical system reports or analytics (e.g., central monitoring dashboards).
• Participate in study team teleconferences with CRO/vendors as necessary, conduct site visits, present findings from QCO visits and monitoring report reviews.
• Serve as the point of contact for CRO for QCO activities and provide guidance on issue resolution. Consult with CTM and CRO to create action plans based on QCO findings to improve monitoring quality.
• CRA Oversight: May perform management of CRAs and oversee monitoring activities including MVR review, accompanied visits and CRA teleconferences.
• Close collaboration with cross functional study team members and critical business partners (e.g., CROs) to implement day-to-day oversight activities and serve as a subject matter expert.
• Perform gap assessments for internal and external (e.g., CRO) SOP/processes. Identify areas for process improvement in consideration of current guidance’s (e.g., ICH GCP) and global regulations (e.g., FDA, EMA, MHRA, PMDA). Effectively leverage lessons learned to elucidate areas for process improvement. Develop related tools, templates, and training materials/work aids.
• Lead training activities for QCO representatives, CRAs, and/or members of cross functional study team.
• Support process improvement initiatives related to risk based and quantitative methods of sponsor trial oversight, which improve the quality of monitoring output/data with a focus on analytics/metrics and automated workflows that leverage systems such as CTMS (e.g., Veeva Vault).
• With a focus on patient safety and data qualit