Senior Clinical Oversight Manager

What You’ll Do:

The Senior Clinical Oversight Manager (COM) is responsible for executing the Clinical Monitoring Oversight visit process and Clinical Oversight Metrics. The Senior COM represents Kailera during Clinical Oversight visits and oversees study execution to ensure compliance with ICH GCP, and applicable regulations. The Senior COM is involved in planning, execution, and delivery of oversight processes including Standard Operating Procedures (SOP) and work instructions. 

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• Develops the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, managing Monitoring Oversight Service Provider (SP) activities, providing study/program/SP level reporting, and leading monthly TMF health checks
• Evaluates and provides recommendations to the study team on Oversight Service Provider activities to ensure the appropriate scope of work, oversight, and training of clinical oversight CRAs to achieve study milestones within agreed upon timelines, budget and quality
• Assigns oversight visits at trial sites based on strategic criteria to evaluate compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Provides oversight on service provider execution of clinical trial activities in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Develops key performance indicators (KPIs) and evaluates service provider operational data against KPIs to identify potential performance gaps
• Collaborates with the Clinical Oversight team, Clinical Quality Management, and Clinical Study Team to implement corrective actions and monitor progress through resolution
• Facilitate resolution of region specific and site management related challenges
• Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups
• Assist with creation and delivery of department initiatives, improvement plans, and/or training
• Selects and oversees Oversight CRAs globally, driving the team to ensure study deliverables are met with efficiency and quality in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements
• Responsible for ensuring Oversight CRAs maintain their sites/studies as inspection ready, including the TMF, for health authority inspections
• Conduct periodic quality visits for Oversight CRAs, as needed
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites
• Support and liaise with clinical site personnel, as needed
• Review contracts and approve vendor invoices

 

Qualifications:

• Minimum of 8+ years of clinical trial experience with strong knowledge of the clinical development process
• Experience with Phase I–III clinical trials, risk-based monitoring, and CRA Management
• Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
• Experience with Vendor oversight, KPI tracking, and issue management
• Strong leadership, collaboration, and communication skills with the ability to manage and motivate team members (e.g., internal staff and external investigators/consultants)
• Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams
• In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
• Ability to manage complexity in a fast-paced environment
• Must have strong clinical study management, communication (oral and written), and analytical skills
• Must be able to travel

 

Education:

• Bachelor’s degree in a scientific or healthcare-related field