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Job Details

Site Start Up Associate - Spain

Company: Premier Research
Location: Madrid, Spain
Reference: 440MS
Closing Date: 22 Dec 16
Type: Contract
Salary (£): Competitive
Benefits: n/a

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. We’re looking for a talented and energetic Site Start Up Associate in Spain to join our team! This is a freelance opportunity to start immediately, likely duration is 6 months.

Requirements:

We’re looking for a talented and energetic Site Start Up Associate to join our team in Spain! This role is offered on a 6 month contract basis with an immediate start.  You will ideally be office based in Madrid.

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 Spanish
Clinical trials support or pharmaceutical industry experience preferred
Office based or homebased
Knowledge of ICH and local regulatory authority drug research and development regulations preferred

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

https://flashrecruit.com/user/JaneDawkins

Apply for this job: 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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