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Job Details

Study Start Up Associate (Netherlands)

Company: Premier Research
Closing Date: 02 Jan 17
Type: Full Time
Salary (£): Competitive

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.


Role: Study Start Up Associate

Location: The Netherlands - Home Based

Contract: Permanent 

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. 

We’re looking for a talented and energetic Study Start Up Associate to join our team in the Netherlands! We are open to the level of candidate for this role and this will be a home based position. 

If you have questions about this role, you can chat with me live, just copy and paste the following link into your browser:

You'll be accountable for:

  • Quality deliverables at the country level for site start-up in one or more components
  • Forecasting submission/approval timelines and ensuring they are adhered to.
  • Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
  • Progressing and tracking site recruitment and approvals according to study timelines
  • Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
  • Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
  • Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
  • Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client

You'll need this to be considered:

  • BSc, MSc or equivalent
  • Prior experience in Clinical Research with experience in start-up activities
  • Prior experience using computerized information systems preferred
  • Ability to read, write, and speak fluent English and Dutch. French is an advantage 
  • Clinical trials support or pharmaceutical industry experience preferred
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Willing to fully home based in The Netherlands

If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realise the importance of communication, building relationships and adhering to the highest quality standards.

Please note:- You must be eligible to live and work in The Netherlands in order to apply for this role.

Keywords:- Study Start Up, Site Start Up, Start Up Specialist, Senior Start Up Specialist, Site Start Up Associate, Study Start Up Associate, The Netherlands, Netherlands, Home Based, French, English, Dutch, Field Based, Pharmaceuticals, Pharma, Permanent, Clinical, Clinical Research, CRO, Clinical Research Organization


Apply for this job: Study Start Up Associate (Netherlands)

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
RG41 2GY
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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