Study Start-Up Manager

  • Location

    Amsterdam, North Holland

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Chris Brough

  • Contact email:

    Chris.Brough@volt.eu.com

  • Job ref:

    BBBH1393_1626205038

  • Published:

    3 maanden geleden

  • Expiry date:

    2021-09-11

We are searching for a Study Start-Up Manager (SSUM) to join a well-established CRO with over 20 years experience in the industry. The Study Start-Up Manager performs and coordinates the site start-up activities within the Study Start-up department of Clinical Operations, while working closely with the Clinical Project Manager.

This important position acts as the main line of communication between the sponsor, site and CRO, and other third parties.

Responsibilities:

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 (including PSVs)
Site activation and contracting
Essential documents collection
Contribute and take part in client evaluations, visits and bid defences
Support in preparation of new proposals
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 Familiarisation meetings, and other Sponsor meetings/TCs
Contribute to the expansion of regulatory and start-up intelligence
Provide training for new hires


Qualifications:

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


Skills:

Strong written and verbal communication skills including good command of English language
Client focused
Representative
Strong social skills
Process and detail orientated
Strong planning and control skills
Excited to work in a fast-paced challenging environment of a growing company
Administrative excellence, with attention to detail and accuracy
Proficiency with various computer applications such as Word, Excel, and PowerPoint required