Senior Manager, Clinical Monitoring Oversight

About the role

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.

Responsibilities

• Developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities.
• 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.
• Maintaining and continually improving standard operating procedures related to clinical monitoring, Risk-Based Quality Management, and clinical trial oversight.
• Presenting QCO role and procedures to study team and CRO and training the CRO on the expectations for QCO activities.
• Overseeing and evaluating 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).
• Participating in study team teleconferences with CRO/vendors as necessary, conducting site visits, presenting findings from QCO visits and monitoring report reviews.
• Serving as the point of contact for CRO for QCO activities and providing guidance on issue resolution.
• Consulting 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.
• Closing 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.
• Performing gap assessments for internal and external SOP/processes, identifying areas for process improvement in line with current guidance and global regulations, leveraging lessons learned to enhance procedures, and developing related tools, templates, and training materials.
• Leading training activities for QCO representatives, CRAs, and/or members of cross functional study team.
• Supporting 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).
• Collaborating with study teams to define meaningful metrics with thresholds/limits (e.g., QTLs, KRIs, KPIs).
• Supporting study teams to develop and build data visualization (analytical) tools.

Qualifications

• Bachelor’s degree in a relevant field.
• At least 8 years minimum experience in clinical research monitoring, preferably including knowledge of infectious disease and other therapeutic areas of relevance to assigned projects.
• A minimum of 5 years clinical trial experience within a pharmaceutical, biotechnology, or CRO required in a role leading others (e.g., managing other CRAs or leading a project team).
• Strong knowledge of GCP regulations (e.g., US, EU, JP) and pertinent U.S. FDA Code of Federal Regulations.
• Broader GXP knowledge is a plus.
• Strong knowledge of risk-based monitoring strategies and tools (e.g., KRIs, QTLs, central monitoring).
• Strong working knowledge of clinical systems: CTMS (e.g., Veeva Vault), EDC, eTMF, eCOA, and data visualization dashboards.
• Demonstrated analytical thinking, attention to detail, and ability to manage multiple priorities.
• Strong written and verbal communication skills, with the ability to present to internal teams, CROs, and external stakeholders.