Associate Director, Monitoring Oversight Management

Summary

Join Apogee Therapeutics as an Associate Director, Monitoring Oversight Management! Lead and manage a global team of Oversight CRAs overseeing CRO monitoring and site management for clinical trials. You will be the primary liaison with in-house CRAs, contributing to a team-centric culture and helping Apogee become a 'Sponsor of Choice.' This role involves developing risk-based monitoring strategies, process improvement, and ensuring compliance with regulations. You will also conduct quality visits, review metrics, and manage team timelines and KPIs. This position requires significant experience in clinical research and leadership.

Requirements

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry
• Minimum 5 years of experience leading a team of CRAs
• Experience working in Phase I-III clinical trials
• Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs), and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment

Responsibilities

• Lead Oversight CRAs globally, ensuring study deliverables are met efficiently and with quality, adhering to SOPs, regulations, GCP, KPIs, and study-specific requirements
• Hire in-house Oversight CRAs
• Contribute to the development and implementation of risk-based monitoring strategies
• Assist the monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas
• Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas
• Facilitate resolution of region-specific and site management-related challenges
• Communicate and resolve issues with clinical vendors, as needed
• Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Train and develop in-house Oversight CRAs and ensure training compliance
• Periodically review monitoring visit reports and metrics, as applicable
• Ensure Oversight CRAs maintain their sites as inspection-ready, including the Trial Master File (TMF), for health authority inspections
• Compile and provide clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Lead, conduct, and document regular meetings with the Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with the creation, review, and revision of departmental SOPs and policies, as applicable
• Assist with the creation and delivery of department initiatives, improvement plans, and/or training
• Conduct periodic quality visits for Senior Oversight CRAs, as needed
• Ensure all site oversight visits are completed within the expected timelines globally
• Oversee all timelines and KPIs for the oversight monitoring team globally
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Preferred Qualifications

• Recent experience working on respiratory, dermatology, and/or gastrointestinal clinical trials
• Recent experience working on trials utilizing risk-based monitoring models
• Certification as a Clinical Research Associate (CCRA) or equivalent
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all-team, in-person meetings to build relationships and problem-solve