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This position is responsible for supporting 2 pivotal phase 3 registration clinical trials as the North America lead, one of which is in set up and one in MAA submission preparation activities including but not limited to, as outlined below:
Experience in managing all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.
Experience in coordinating interdisciplinary activities involving study conduct: , management of regional activities of CROs and vendors, monitoring visit review , study drug supply management and ordering, development of contracts and budgets, regulatory document filing, planning for interim analysis and tracking data.
Collaborate with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
Regional oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
Communicate with study sites and third-party vendors, proactively recognizes problem situations and inform team members to enable issue resolution.
Phase III study experience is a must, with experience of managing regional components of database locks
Electronic data capture experience required, particularly Inform, as a plus
Working experience on global clinical studies and with teams not immediately co-located
Contribute to individual and team development through training initiatives and team building activities.
Requirements:
Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum.
Minimum 7-10 years experience in the pharmaceutical industry in a position performing clinical operations functions.
Must have been in a role as a regional manager on global phase III studies for at least 3 years
Strong communication skills, must be able to work globally
Experience in CNS (ideally Epilepsy) therapeutic area preferred, but not required.
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