Site Activation Specialist - Europe

Location: Amsterdam, North Holland
Job Type: Blijvend
Specialisation: Life Sciences
Salary: Negotiable
Reference: BBBH1389_1626172148
Contact: Chris Brough
Email: email Chris
We are searching for a Site Activation Specialist based in Europe (close to Amsterdam, NL or Cologne, Germany ideally) to join a boutique CRO with over 20 years experience in the industry. The Site Activation Specialist (SAS) performs and coordinates the site start-up activities within the Study Start-up department of Clinical Operations. This important position monitors feasibilities (post study award), pre-study visits, contract negotiations, and the collection of essential documents.

The SAS acts as main line of communication between investigators and the sites through the initial phase of a clinical study, through to the Site Initiation Visit.

Responsibilities:

Main line of communication with sites (potential or existing), investigators and study teams
Perform feasibilities both Pre and Post-award
Create lists of potential investigators and sites
Design and develop feasibility questionnaires
Develop good working relationships with investigators and sites
Perform pre-study visits (PSV)
Assess sites' and investigators' suitability
Negotiate various contracts (including budget) with sites, investigators and third parties
Support management of regulatory (site specific) requirements
Organise hand-over of sites prior to Site Initiation Visit (SIV)


Qualifications:

Life science, healthcare and/or business degree
Minimum 3 years of relevant work experience
Minimum 3 years of experience in drug development and/or clinical research
Good understanding of site management and monitoring, preferably through CRA experience.
Good knowledge of ICH-GCP, 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