Site Management Lead - Clinical Research

About the role

The Site Management Lead (SML) reports to the Associate Director/Senior Manager, Global Site Management and provides direction and operational expertise for clinical site management integrity, quality and timeliness in assigned studies. The role can act as the overall CSM functional study strategy leader and/or manage area site execution together with other SMLs, depending on the size, complexity and geographic scope of the studies.

Key responsibilities

• Analyse study timelines and assumptions to confirm CSM deliverables are feasible, and support and communicate resource needs with Country Leaders.
• Own the study-level site monitoring strategy (documented in the Site Monitoring Plan) and the Site Engagement Strategy.
• Keep study and area timelines on track across the study lifecycle and provide timely information to country teams.
• Drive site-level activities such as site selection, activation, engagement, protocol adherence and close-out, and ensure sites close according to the Site Closure Plan.
• Oversee monitoring activities with other SMLs, drive CSM deliverables during data snapshots and database locks, and ensure inspection readiness throughout the study.
• Identify, evaluate and mitigate risks, contribute to the Risk Assessment and Mitigation Plan (RAMP), and escalate compliance issues while analysing trends for continuous improvement.
• Contribute to the completeness of CSM documents and the TMF, and collaborate with the Clinical Study Team on study execution.

Required profile

• Bachelor's degree or equivalent, typically in a para-medical or scientific field.
• At least 5 years of industry clinical research experience; 2 years of monitoring, project management or equivalent experience on a global study is preferred.
• Preferred exposure to study initiation through completion in multiple phases (Phase II and III, Phase I in patients) and experience across several therapeutic areas.
• Good written and verbal communication, strong planning and organisational skills, and the ability to work autonomously in a matrix team.
• Fluent English and strong presentation skills.

Required skills

• Competence in standard business procedures (SOPs, ICH, global regulations, ethics and compliance).
• Advanced skills in Microsoft Word, PowerPoint, Excel and OneNote.