Site Start-Up Manager

  • Location

    Israel

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    €55000 - €75000 per annum

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • Job ref:

    77821-PHARM-CBG_1611311299

  • Published:

    8 months ago

  • Expiry date:

    2021-03-23

  • Startdate:

    ASAP


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