Hobson Prior currently have the opportunity for a Study Lead Monitor to join a world-wide life science organisation who are dedicated to ground-breaking scientific research and discovery.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Leads and motivates the geographically dispersed Country Lead Monitors and Clinical Research Associates assigned to a given study.
• Leads regular CLM meetings and contributes to regular Core Team Meetings.
• As a core member of the Study Team, the SLM works in close collaboration with the StM and the Study Team.
• Manages the operational aspects of the site feasibility to ensure study processes and expectations correspond to the practicality of conducting the study from the operational perspective, from site feasibility to study close out.
• In case SLM is assigned to an out-sourced program under a Partnership Operating Manual (POM), the SLM acts as an 'oversight manager'.
• Represents monitoring and site management aspects in the Core Study Team.
• Works in close collaboration with the Country teams, StM, Study Data Manager (SDM), EDC Developer, Study Medical Expert, IxRS and Medication Manager (IMM) and other functions.
• Works in a matrix organization and ensures consistent information flow from Study Team to country teams and vice versa.
• Responsible and accountable for the study specific training and quality oversight of monitoring and site management activities for the assigned study.
• Reviews Country Monthly Reports, tracks operational study activities and progress, and consolidates information as required by StM.
• Responsible and accountable for developing the Monitoring Plan and appendant study specific forms, and substantially contributes to the development of recruitment and retention strategies and tools.
• Contributes to the protocol and study and oversight plan development with regard to monitoring and operational aspects
• Conducts co-monitoring visits as specified in the study oversight plan
• Reviews the monthly country report to identify country issues and any operational study related trends
• Is an active member of the Fraud & Misconduct Team and Serious Breach Team as applicable
• Contributes to development of the Monitoring Strategy
• Contributes to Study Risk levelling
• Ensures all relevant IT-systems are updated with current and accurate information (e.g. IMPACT).
• Any other assigned duties.

Key Skills:

• Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making.

Requirements:

• A Bachelor's degree or equivalent with 5 years of relevant Healthcare experience including 4 years monitoring & site management experience and 2 years of CLM/country project management experience.
• As the expert of monitoring and site management processes and activities on the global study team, this position requires in-depth knowledge of Good Clinical Practices (GCP) and international regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.