Responsabilities:

Responsible for delivery of Study Start-up activities within budget and time and with good quality, including:
Clinical Trial Applications
Feasibilities (post-award)
Identification and evaluation of sites and investigators (incl PSVs)
Site activation
Site contracting
Essential documents collection
Ensure study set-up in compliance with protocol, ICH-GCP and applicable local regulatory requirements
Main line of communication with potential clients, sponsors and internal study team members
Contribution to and representation during External Kick-off meetings, Study Familiarization meetings, and other Sponsor meetings/TCs
Contribute to the expansion of regulatory and start-up intelligence


Requirements:

Life science, healthcare and/or business degree
Minimum 2 years of relevant work experience in study start-up
Minimum 5 years of experience in drug development and/or clinical research
Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements