Clinical Study Assistant

As a CSA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• The Global Clinical Study Assistant MAO, assists with local project management activities of clinical trials from start-up through to closeout activities. Work in close collaboration with the Global Trial leader (GTL) to ensure overall study delivery at the country level.

  • Schedules study management team meetings for each project assigned and maintains documentation from meetings.
  • Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
  • Ensures study compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring upto-date, complete and accurate status.
  • Maintains internal project specific study sites to ensure availability of all central project documents.
  • Liaises with external service providers and contract research organizations as needed.
  • Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
    training requirements.
  • Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
  • Full utilization by timely and accurate time reporting.

What do you need to have?

• Bachelor’s degree or equivalent experience
• Excellent independent time management skills.
• Experience in clinical research experience in the pharmaceutical industry or CRO. At least 1 year in a CTA role.
• Fluency in English