Company: i-Pharm Consulting
Closing Date: 25 Oct 16
Salary (£): Negotiable
Clinical Trial Assistant (m/w) HamburgOur client, an international pharmaceutical company is looking for several CTAs to work office-based in Hamburg, to start as soon as possible. This is a fantastic opportunity for you to develop your career within Clinical Operations. ...
Clinical Trial Assistant (m/w) Hamburg
Our client, an international pharmaceutical company is looking for several CTAs to work office-based in Hamburg, to start as soon as possible. This is a fantastic opportunity for you to develop your career within Clinical Operations.
• Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance
• Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM/ Lead CRA or CRA
• Set up the Investigator’s File as directed by the CRA
• Maintain the SMF as directed by the Lead CRA/Project Manager
• Coordinate study supplies as directed by the CRA
• Drafts and/or assists with the preparation of trial-related documents, tools and templates
• Arrange internal and external meetings
• Taking part in Study Team meetings and be responsible for the minutes
• Assist in activities associated with audits and regulatory inspections
• SMF completion and preparation of shipment to sponsor as directed by the Lead CRA /CRA
• Collection of appendices for final Clinical Study report
• Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees
• Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.
• Bachelor’s Degree would be an advantage
• Great written and communication skills in German and English
• Good organizational skills
• About one year experience in Clinical Operations
• Knowledge of GCP/ICH guidelines
• Good software and computer skills
• Must possess permission to work in the EU
If you wish to apply, send your CV in English to:
t: +49 (0) 89 71 677 25 15
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