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Job Details

Site Start Up Associate

Company: Premier Research
Location: Darmstadt, Germany
Reference: 765JM
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

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. New business wins means we are currently looking for a talented and energetic Site Start-Up Associate to join our team in Germany!

Requirements:

The Site Start-Up Associate performs all country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. This includes but is not limited to the following tasks: Liaise with the Site Recruitment Specialist, as applicable, to provide study start-up metrics and site contact information for the Investigator Database, coordinate with the Study Maintenance Associate to disseminate the Investigator Site File binders, essential document collection and review, tracking, site communications, Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up, customs clearance and import/export license management, transition all study start-up complete sites to the Study Maintenance Associate within timeline and in general all needed preparations for site activation.

You will be responsible 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.

To be considered for this role you will need:

  • An undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
  • Related experience (health sciences, biology degree)
  • 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

 

 

Apply for this job: Site Start Up Associate

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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