Site Management Lead

Role Summary

The Site Management Lead (SML) provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The role may serve as the overall CSM functional study strategy leader or manage area site execution activities in collaboration with other SMLs, depending on study size, complexity, and geographic scope.

Responsibilities

• Study Level CSM Planning and Strategy:
  • Analyze study timelines and assumptions to confirm feasible CSM deliverables
  • Communicate CSM resource needs with Country Leaders aligned to deliverables and milestones
  • Accountable for study level site monitoring strategy, documented in Site Monitoring Plan
  • Lead Site Engagement Strategy
• Study Execution Accountability and Monitoring Oversight:
  • Maintain study-level and/or area-level timelines across the study lifecycle
  • Provide timely study information for country-level teams to execute milestones
  • Drive site-level activities at study or area level, including site selection, activation, site engagement, protocol adherence, and close out
  • Oversee monitoring activities at study and/or area level, ensuring quality deliverables, status tracking, and milestone adherence
  • Drive CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan
  • Ensure sites are closed per Site Closure Plan
• RBQM:
  • Identify, evaluate, and mitigate risks; contribute to Risk Assessment and Mitigation Plan (RAMP)
  • Collaborate with other SMLs and stakeholders to manage risks and align with study execution
  • Ensure site compliance and analyze trends for continuous improvement
• Inspection Readiness and TMF:
  • Provide inputs on expected CSM documents at study level and drive TMF completeness for CSM artifacts
  • Ensure ongoing CSM Inspection Readiness activities are completed at the study level

Qualifications

• Bachelor‚Äôs Degree or equivalent in a (para)medical or scientific field
• Minimum 5 years of industry clinical research experience; preferred 2 years of monitoring or project management or equivalent on a global study
• Preferred exposure from study initiation through completion in multiple phases (Phase II/III; Phase I in patients); experience across multiple therapeutic areas desirable
• Strong core and technical competencies in managing components of clinical trials
• Good communication and leadership abilities; able to influence in a matrix environment
• Competent in standard procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Excellent written and verbal communication; strong planning and organizational skills; ability to work in a dynamic, fast-paced environment
• Ability to create and deliver presentations
• Ability to work well within a matrix team and autonomously; proactive thinker
• Advanced skills in Microsoft Word, PowerPoint, Excel, and OneNote

Skills

• Project management
• Site management and monitoring
• Risk-based quality management
• TMF management
• Stakeholder collaboration
• Data management and database locks

Education

• Bachelor‚Äôs Degree or equivalent in a relevant field

Additional Requirements

• None beyond qualifications listed