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Job Details

Freelance Site Start Up Associate

Company: Premier Research
Location: Germany
Reference: FREELANCE SSUA-GERMANY
Closing Date: 22 Dec 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

Requirements:

Role: Site Start Up Associate 

Location: Office Based in Darmstadt, Germany OR Home Based, Germany 

Contract Type: Freelance for 6 months 

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 Germany! This is a freelance opportunity for 6 months and we are ideally looking for 0.8 FTE.

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.

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 Germany - experience in Switzerland and Austria ia a bonus
  • Experience in Pharma and Medical Devices trials 
  • Prior experience using computerized information systems preferred
  • Ability to read, write, and speak fluent English; fluent in host ountry 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
  • Available to start immediately
  • 0.8 FTE 

You must be eligible to live and work in Germany in order to apply for this role. 

KEY WORDS: Freelance, Contract, Start Up, Start Up Specialist, Site Start Up, Study Start Up, Study Start Up Specialist, Germany, Home Based, Office Based, Clincial Research, CRO, Contract Research Organization, Biotechnology, Biotech, Pharmaceuticals 

Apply for this job: Freelance 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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