Senior Manager – Clinical Monitoring Strategy & Optimization

Oruka Therapeutics

Senior Manager/Associate Director of Clinical Monitoring Strategy and Optimization overseeing clinical monitoring activities for a biotech company. Leading CRO performance and providing operational leadership in clinical trials around the globe.

Posted 6/6/2026full-timeMenlo Park • California, Massachusetts • 🇺🇸 United StatesSenior💰 $161,000 - $208,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence.
Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance.
Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Establish effective CRO oversight and governance processes.
Monitor CRO performance through KPIs, metrics, and regular operational reviews.
Escalate and resolve study conduct issues proactively.
Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.
Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.
Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.
Develop and refine SOPs, work instructions, templates, and monitoring processes.
Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
May directly manage CRAs and/or Clinical Trial Managers as the organization grows.
Mentor junior clinical operations staff and contribute to team development.
Foster a collaborative, accountable, and quality-focused culture.

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, or related discipline.
6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments.
Significant experience overseeing clinical monitoring activities in interventional clinical trials.
Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
Experience managing CROs and external vendors.
Demonstrated ability to work effectively in a small, fast-moving biotech environment.
Excellent communication, organizational, and problem-solving skills.
Extensive domestic and international travel as needed (approximately 60-80%).
Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.

Benefits

Comp & perks

Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

ATS Keywords

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Hard Skills & Tools

clinical monitoringrisk-based monitoringCRO managementclinical trial managementmonitoring plansrisk management plansstudy oversight plansSOP developmentKPI monitoringcompliance review

Soft Skills

communicationorganizationalproblem-solvingmentoringcollaborationaccountabilityleadershipcontinuous improvementteam developmentproactive issue resolution

Certifications

Bachelor’s degreeadvanced degree (MS, MPH, PharmD, PhD, RN)