Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
O
Oruka TherapeuticsBiotech
Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.Full-TimeManager
Salary161,000 - 208,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 6-8+ years of clinical operations experience
Requirements
- Bachelor’s degree in life sciences, nursing, or related discipline.
- 6-8+ years of clinical operations experience in biotech, pharma, or CRO environments.
- Significant experience overseeing clinical monitoring activities in interventional 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.
- Ability to travel domestically and internationally (60-80%).
Responsibilities
- Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials.
- Serve as the internal expert for monitoring strategy and risk-based monitoring.
- Provide oversight and management of CROs, CRAs, and external vendors.
- Review monitoring plans, metrics, and deliverables for quality and compliance.
- Partner cross-functionally with Clinical Development, Regulatory Affairs, and QA.
- Establish effective CRO oversight and governance processes.
- Ensure compliance with ICH-GCP, SOPs, and global regulations.
- Help build scalable clinical monitoring infrastructure and refine SOPs.
- Drive continuous improvement initiatives and inspection readiness activities.
- Mentor junior staff and potentially manage CRAs/Clinical Trial Managers.
View Full Description & ApplyYou'll be redirected to the employer's site
