Description:
In this role the CSM will work with the CSM Team supporting allocation, initiation and conduct of trials
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Supporting study feasibility and country patient commitments in collaboration with Country Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
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Ensuring that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
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Supporting local Drug Supply Management, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
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Oversees local vendor performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
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Ensuring sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
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Maintaining a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
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Supporting the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
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Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
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Works with CSM team to oversee local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to companies standards and local and international regulations
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Supports Leads/chairs at local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
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Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
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Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
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Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
- Minimum 3 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of working within in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and companies standards
- Experience with site intercommunications
- Strong communication skills, written and verbal.
A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable