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Job Details

Senior Site Start-up Associate (Spain)

Company: Premier Research
Location:
Reference: SUA-SPAIN
Closing Date: 31 Aug 18
Type: Permanent
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: Senior Site Start Up Associate 

Location: Madrid, Spain (Office Based)

Contract Type: Permanent

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 Senior Site Start-Up Associate to join our team in Spain. This is a permanent opportunity.

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.
  • 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

KEY WORDS: Site Start Up Associate, Study Start Up, Start Up Specialist, Senior Start Up Specialist, SSUA, SUA, Permanent, CRO, Contract Research Organization, Madrid, Spain, Clinical Research, Submissions Specialist, Submissions, Pharma 

Apply for this job: Senior Site Start-up Associate (Spain)

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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