Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
New
O
Oruka TherapeuticsBiotech Pharmaceutical
Menlo Park, California, United States; Remote; Waltham, Massachusetts, United StatesFull-TimeManager
Salary$161,000 - $187,000 (Sr. Manager) and $182,000 - $208,000 (Associate Director)
Apply NowOpens the employer's application page
Job Details
- Experience
- 6-8+ years
Requirements
- 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%).
- Experience in rare disease, immunology, or oncology preferred.
- Experience supporting NDA/BLA-enabling studies preferred.
- Experience implementing risk-based monitoring strategies preferred.
Responsibilities
- 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.
- Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.
- Develop and refine SOPs, work instructions, templates, and monitoring processes.
- Support inspection readiness activities and regulatory inspections.
View Full Description & ApplyYou'll be redirected to the employer's site
