Company
Biotech
SeniorManager/AssociateDirectorClinicalMonitoringStrategy&Optimization
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“Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization. Skills: clinical monitoring strategy, vendor management, CRO oversight, risk-based monitoring, regulatory compliance. Lead clinical monitoring strategy and execution across Phase I–III global and domestic trials, ensuring high-quality delivery, compliance, and operational excellence. Oversee CROs, CRAs, and external vendors while developing robust governance frameworks and performance oversight models.”
What You'll Achieve.
Opportunity to contribute to high-impact clinical programs with real patient outcomes.
Industry & Context.
problem-solving; risk identification; corrective and preventive actions
Ability to thrive in ambiguity and contribute to a scaling biotech environment.
What They're Looking For.
Must Have
Seasoned clinical operations professional with leadership, vendor management, and monitoring expertise in biotech, pharma, or CRO environments. Ability to operate confidently in both strategic and tactical capacities in a lean and fast-moving organization.
Nice to Have
Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred. Experience in complex therapeutic areas such as immunology, oncology, or rare disease is a plus.
What You'll Do.
Lead clinical monitoring strategy and execution across Phase I–III global and domestic trials
ensuring high-quality delivery
and operational excellence. Oversee CROs
and external vendors while developing robust governance frameworks and performance oversight models.
How You'll Work.
Team & Collaboration
Driving cross-functional collaboration with clinical, regulatory, data, and quality teams to ensure study alignment.
Communication Scope
Excellent communication
Process & Methodology
risk management, stakeholder management
Full Job Description
## Accountabilities 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 col
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