delivering support to the Early Stage Development Europe Operational team. He/she will be providing operational support and project support (responsible for in-house activities as well as for compliance with processes required to initiate, maintain, support and close out the early stage clinical trials managed by the department) and will carry out tasks for the support of clinical grants.
candidate will be supporting an average of 4-5 trails, all in different stages of Phase I. For this hybrid role, the tasks will include but are not limited to: ESD studies assistant tasks: – Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials. – Create Essential Documents Repository. – Assemble and track availability of all essential documentation required for study conduct. – Provide professional presentation of study materials for investigator/vendor or country operations meetings – Liaise with sites and in house departments to ensure appropriate regulatory follow-up – Organization and documentation (minutes) of project team meetings where need be – Operational and project support activities, including, but not limited to: – Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting and clinical grants payments – Follow-up/check final accountability of IMP and return or destruction as appropriate – Possibility for SME roles: CTMS, TMF steward, SIP, CLMS, Safety reporting tracking