Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

About the role

The Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization role is currently being offered by a partner company on behalf of a biotechnology firm. This position is open to candidates based in the United States.

Responsibilities

• Lead clinical monitoring strategy and optimization initiatives, ensuring high-quality trial execution while establishing robust operational processes.
• Develop and implement monitoring strategies, including risk-based monitoring approaches and centralized monitoring methodologies.
• Provide oversight of CROs, CRAs, and external vendors to ensure performance, quality standards, timelines, and budget objectives are achieved.
• Review monitoring plans, site management activities, trip reports, metrics, and clinical deliverables to ensure compliance and operational excellence.
• Establish vendor governance processes, monitor key performance indicators, and proactively address study execution challenges.
• Partner with Clinical Development, Clinical Science, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Quality teams to support the creation and refinement of clinical operations documents.
• Contribute to inspection readiness activities and support regulatory inspections and audits.
• Build scalable clinical monitoring infrastructure, SOPs, templates, and operational processes for a growing organization.
• Drive continuous improvement initiatives focused on trial quality, efficiency, and operational maturity.
• Mentor clinical operations team members and contribute to building a collaborative, accountable, and quality-driven culture.

Requirements

• Experienced clinical operations professional with strong expertise in clinical monitoring, vendor management, and regulatory compliance.
• Extensive experience overseeing clinical monitoring activities for interventional clinical trials.
• Proven experience managing CROs, external vendors, and clinical trial partnerships.
• Strong knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
• Ability to work effectively in a lean, rapidly changing biotechnology environment with a high level of ownership.
• Strong communication, organizational, analytical, and problem-solving skills.
• Experience supporting NDA/BLA-enabling studies and regulatory inspections preferred.
• Background in rare disease, immunology, oncology, or related therapeutic areas preferred.
• Prior people management or mentoring experience is a plus.
• Willingness and ability to travel extensively as needed, approximately 60-80%.

Benefits

• Competitive compensation package with a base salary ranging from $161,000 to $208,000 USD depending on level, experience, and qualifications.
• Equity participation and performance-based bonus opportunities.
• A comprehensive benefits package designed to support employee well-being.
• An opportunity to work remotely or in a hybrid model depending on location.
• A supportive, inclusive, and collaborative workplace culture.
• Opportunities for professional growth and development.
• The chance to directly contribute to the development of innovative therapies that can improve patient outcomes.