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.
We’re looking for a talented and energetic Site Start-Up Associate to join our team in Spain. This is a permanent opportunity.
The successful hire will join the exisiting SUA team in Spain and, as such, must be able to demonstrate the ability to work as part of a team and also independently.
In addition, they must have sufficient experience to represent Spain from an SSU point of view and have comprehensive knowledge and experience of the Spanish regulatory system and submission process.
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.
Setting up and 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 Spain
Prior experience using computerized information systems preferred
Ability to read, write, and speak fluent English; fluent in host country language
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 or from June / July 2018