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Job Details

Study Start Up

Company: Docs Global (Continental Europe)
Location: germany
Reference: AS-019171
Closing Date: 04 Nov 16
Type: Full Time
Salary (£): Competitive

Job Summary:

Study Start Up (m/f) - office-based near Frankfurt am Main.


Our client is one of the world's leading pharmaceutical companies operating in various therapeutic areas, is looking for a 

Study Start Up (m/f) - office-based near Frankfurt am Main.

EU SA Associate will drive process improvement to aggressively reduce site activation timelines using
Critical Chain Project Management (CCPM) techniques or other appropriate project management tools. EU SA Associate will provide technical expertise and will be the main contact for clinical trial
Applications, Ethical Review Board (ERB) and other applicable entities. EU SA Associate will provide
consultation for study feasibility and site evaluation process. EU SA Associate will ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards and Procedures and that Sponsor Master Files are inspection ready

•    Prepare and manage regulatory submissions in countries of responsibilities via European regulatory processes, where applicable, to support clinical research
•    Coordinate translation process for all required trial documents and oversee the quality of final documents
•    Prepare the initial country/site study level ICFs, as well as revisions as a result of protocol amendments, risk profile updates, etc. Contribute to the country specific ICF template review
•    Develop and maintain relationships with ERB/CA, where applicable
•    Maintain the relevant sections of study Trial Master Files (TMF), any internal reporting systems, and ensure they are inspection ready at all times
•    Negotiate contracts with Institutions and investigators partnering with regional and global functions to process requests outside of previously agreed parameters
•    Assist project teams with site selection activities as required
•    Review study documents as required, e.g., patient directed materials


•    Bachelor of Science or equivalent
•    At least 2 years Clinical Research experience
•    Strong, technical, operational Clinical Operations Expertise
•    Strong experience in study start-up or equivalent
•    Strong knowledge of regulations, legislation and guidelines applicable for the conduct of
clinical studies
•    Fluent in English and German

Apply for this job: Study Start Up

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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