Job Title: Sr. Manager/Associate Director, Clinical Monitoring Strategy and Optimization

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview:

We are seeking an experienced and highly motivated Sr. Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment.

The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization.

Key Responsibilities:

Clinical Monitoring Leadership

• 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.

Vendor and CRO Oversight

• Establish effective CRO oversight and governance processes.
• Monitor CRO performance through KPIs, metrics, and regular operational reviews.
• Escalate and resolve study conduct issues proactively.
• Participate in vendor selection, qualification, and contract review activities.

Trial Execution and Compliance

• 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.
• Contribute to inspection readiness activities and support regulatory inspections and audits.

Operational Process Development

• 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.
• Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.

Team Leadership and Mentorship

• 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.

Qualifications:

Required

• 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%).

Preferred

• Bachelor’s degree or equivalent required.
• Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.
• Experience in rare disease, immunology, oncology, or other relevant therapeutic areas.
• Experience supporting NDA/BLA-enabling studies and regulatory inspections.
• Experience implementing risk-based monitoring strategies and oversight models.
• Prior people management experience.

Desired Leadership Competencies

• Strategic thinker with strong execution skills
• Comfortable with ambiguity and rapid change
• Hands-on and solutions-oriented
• Strong collaborator and relationship builder
• High attention to detail and commitment to quality
• Ability to influence cross-functional teams and external partners

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for Sr. Manager is $161,000 - $187,000 and for Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day