Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

Accountabilities: The Senior Manager/Associate Director will lead clinical monitoring strategy and optimization initiatives, ensuring high-quality trial execution while helping establish robust operational processes. The role requires strong collaboration with internal teams and external partners to maintain compliance, improve efficiency, and support successful clinical development programs.

Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials across domestic and global programs.

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.

Support the creation and refinement of clinical operations documents, including monitoring plans, risk management plans, study oversight plans, and clinical trial management plans.

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:

The ideal candidate is an experienced clinical operations professional with strong expertise in clinical monitoring, vendor management, and regulatory compliance. They should be comfortable balancing strategic responsibilities with hands-on execution in a fast-paced biotechnology setting.

Bachelor’s degree in life sciences, nursing, or a related discipline required; advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.

6–8+ years of clinical operations experience within biotechnology, pharmaceutical, or CRO environments.

Extensive experience overseeing clinical monitoring activities for interventional clinical trials.

Strong knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.

Proven experience managing CROs, external vendors, and clinical trial partnerships.

Experience developing monitoring strategies, risk-based monitoring models, and operational oversight frameworks.

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:

The role offers a competitive compensation package and an opportunity to contribute to meaningful scientific advancements within an innovative biotechnology environment.

Competitive base salary ranging from $161,000 to $208,000 USD depending on level, experience, and qualifications.

Equity participation and performance-based bonus opportunities.

Comprehensive benefits package designed to support employee well-being.

Opportunity to work remotely or in a hybrid model depending on location.

Supportive, inclusive, and collaborative workplace culture.

Professional growth and development opportunities.

Opportunity to directly contribute to the development of innovative therapies that can improve patient outcomes.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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