Site Management Lead

About This Role

This role provides direction and operational expertise for Clinical Site Management (CSM) activities in assigned studies, ensuring integrity, quality, and timeliness. It involves leading study strategy, overseeing monitoring activities, and managing risks in a fast-paced environment.

Responsibilities

• Serve as the overall CSM functional study strategy leader or manage area site execution activities
• Direct site monitors in a matrix environment and act as a liaison between monitors, study strategy leader, and Clinical Study Team
• Drive study level global and/or area level CSM deliverables by targeted timelines
• Analyze study timelines and overall study assumptions to confirm CSM deliverables are feasible
• Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones
• Accountable for study level site monitoring strategy, documented in Site Monitoring Plan
• Accountable to set and lead Site Engagement Strategy
• Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; contribute to Risk Assessment and Mitigation Plan (RAMP)
• Provide inputs on expected CSM documents at the study level and drive TMF completeness for CSM artifacts

Requirements

• Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field
• 5+ years of industry clinical research experience
• Good communication skills and demonstrated leadership abilities
• Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Demonstrated good written and verbal communication skills including fluency in English
• Excellent planning and organizational skills
• Ability to work effectively and efficiently in a dynamic, fast-paced environment
• Strong ability to create and deliver presentations
• Able to work well within a matrix team and autonomously

Qualifications

• Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• A minimum of 5 years of industry clinical research experience and preferred 2 years of monitoring or project management or equivalent experience on a global study.

Nice to Have

• 2 years of monitoring or project management or equivalent experience on a global study
• Exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients)
• Experience in multiple therapeutic areas or disease state/indications

Skills

* Required skills

Benefits