Site Start-Up Manager
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Location
Israel
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Sector:
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Salary:
€55000 - €75000 per annum
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Contact:
Carlos Biggemann
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Contact email:
Carlos.Biggemann@volt.eu.com
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Job ref:
77821-PHARM-CBG_1611311299
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Published:
over 3 years ago
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Expiry date:
2021-03-23
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Startdate:
ASAP
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Consultant:
ConsultantDrop
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