Clinical Trial Assistant

Clinical Trial Assistant

Affimed

Heidelberg, Germany

Responsibilities

  • Support the Clinical Team in all aspects of the organization and management of clinical trials according to ICH-GCP, applicable regulations and SOPs;
  • Support Trial Team in generating and updating trial related documents and manuals;
  • Provide support in compilation and submission of packages for clinical trial applications to Health Authorities and Ethics Committees/Institutional Review Boards;
  • Support in all administrative tasks in the context of clinical trials;
  • Accurately monitor, update and maintain trial status and overview lists;
  • Track status of trial-related tasks;
  • Support trial-related invoicing and budgeting;
  • Set up, maintain and review trial master files including supporting quality control of documents;
  • Support contract management for Clinical Department: preparation of contractual documents, shipment, follow-up on return of documents, as well as filing, archiving and maintenance of internal database;
  • Correspond with internal and external partners and vendors;
  • Support the organization and coordination of internal and external meetings;
  • Prepare and review meeting minutes;
  • Collaborate with the Clinical Department in definition and development of internal processes, e.g. SOP writing.

Requirements

  • Scientific degree, medical documentation officer certification or equivalent medical, scientific or pharmaceutical education;
  • Long-term experience (more than 2 years) as Clinical Trial Assistant in biotech/pharmaceutical industry or at a CRO;
  • Solid knowledge of ICH-GCP and regulations governing the conduct of clinical trials;
  • Very good English skills, both written and spoken;
  • Excellent communication skills;
  • Very good organizational skills and team spirit;
  • Results-oriented approach, flexible and proactive attitude towards changing needs; willingness to work on different projects simultaneously;
  • Ability to systematically perform activities in a timely and accurate manner, reliability, good time management;
  • Ability to work in a structured manner even under time pressure, experience in dealing with external parties;
  • Ability to confidentially handle sensitive data and information;
  • Very good knowledge of MS Office.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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