Position at Premier Research Group Limited Premier Research helps highly innovative biotech and specialty pharma companies transform life-
changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.
You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic Site Start-Up Associate to join our team to cover Netherlands and Belgium. This is a Contractor opportunity with 0.
25-0.50 FTE coverage for the months of July and August 2018.
Imagine. Inspire. Innovate. Impact. With Us.
You'll be accountable for :
Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
Liaising with internal team members to review areas that impact study start-up and sharing start-up information with the project team.
Providing country-level intelligence on site start-up. Ensuring that local country regulatory intelligence is maintained on the central repository, e.
g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications / applications to any other local / federal / national body, and import / export license applications where these are obtained with RA applications.
Maintaining a country folder with country Ethics Committees / Review Board and local authority addresses and requirements.
Pending country in use, the SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.
Providing quality review of the informed consent and adapting the template as appropriate.
Working within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and / or ISO14155 and any other requirements mandated by the study.
Negotiation and completion of Clinical Trial Agreements, CTA Amendments and study budgets.
You'll need this to be considered :
An undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
Experience within submissions and site start up in The Netherlands and Belgium
Prior experience using computerized information systems preferred
Ability to read, write, and speak fluent English. Fluent in local language (Dutch).
Clinical trials support or pharmaceutical industry experience preferred
Office based or clinical employment experience preferred
Knowledge of ICH and local regulatory authority drug research and development regulations preferred
Ideally available to start immediately