Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization based in the United States.

This role is a key strategic and operational leadership position responsible for shaping how clinical monitoring is designed, executed, and continuously improved across global clinical trials. You will act as a core driver of monitoring excellence, ensuring high-quality oversight of CROs, CRAs, and external vendors in a fast-paced biotech environment. The position blends hands-on operational execution with high-level strategy, requiring the ability to build scalable processes while ensuring inspection-ready compliance. You will collaborate closely with cross-functional teams including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and Quality Assurance to ensure alignment across the trial lifecycle. This is a high-impact role where your decisions directly influence study quality, efficiency, and regulatory success. It offers the opportunity to build and optimize foundational clinical monitoring infrastructure within a growing organization.

You will lead clinical monitoring strategy and execution across Phase I–III global and domestic trials, ensuring high-quality delivery, compliance, and operational excellence. You will oversee CROs, CRAs, and external vendors while developing robust governance frameworks and performance oversight models. Key responsibilities include:

• Defining and implementing monitoring strategies, including risk-based and centralized monitoring approaches
• Overseeing CRO/vendor performance through KPIs, metrics, audits, and governance reviews
• Reviewing monitoring plans, trip reports, and study deliverables to ensure quality and compliance with regulatory standards
• Supporting inspection readiness activities and contributing to regulatory inspections and audits
• Developing and optimizing SOPs, templates, and operational workflows to improve scalability and efficiency
• Driving cross-functional collaboration with clinical, regulatory, data, and quality teams to ensure study alignment
• Identifying operational risks, escalating issues, and implementing corrective and preventive actions
• Potentially mentoring or managing clinical operations staff as the organization grows

Requirements:
This role requires a seasoned clinical operations professional with strong leadership, vendor management, and monitoring expertise in biotech, pharma, or CRO environments. You will be expected to operate confidently in both strategic and tactical capacities in a lean and fast-moving organization. Key qualifications include:

• 6–8+ years of clinical operations experience with significant exposure to clinical monitoring oversight in interventional trials
• Strong expertise in ICH-GCP, FDA, EMA, and global clinical trial regulations
• Proven experience managing CROs, CRAs, and external clinical vendors
• Demonstrated ability to design or improve monitoring strategies, processes, or operational frameworks
• Experience with risk-based monitoring and inspection readiness activities
• Strong cross-functional collaboration skills across clinical, regulatory, and data functions
• Excellent communication, problem-solving, and organizational abilities
• Ability to thrive in ambiguity and contribute to a scaling biotech environment
• Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred but not required
• Experience in complex therapeutic areas such as immunology, oncology, or rare disease is a plus

Benefits:

• Competitive base salary with performance-based bonus and equity opportunities
• Comprehensive medical, dental, and vision insurance coverage
• Paid time off, sick leave, and parental leave policies
• Hybrid or fully remote flexibility depending on location
• Opportunity to contribute to high-impact clinical programs with real patient outcomes
• Strong professional development opportunities in a growing biotech environment
• Collaborative and science-driven culture with high visibility across leadership
• Exposure to global clinical trial operations and regulatory interactions