We are searching on behalf of an international pharmaceutical / chemical company for administrative support in a medical environment. The position is based in Darmstadt.
Administrative support for the establishment, implementation and maintenance of the global structure and system for archiving of all essential documents from clinical trials
• Maintenance of the internal repository (database) on Trial Master Files (TMF) due for archiving and Trial Master Files already archived in the external archiving facility; adjustment and advancement of the internal repository as needed.
• Support for the design, the development and maintenance of all document tracking systems and related tools as required to oversee status of archived essential documents
• Support development of archiving processes for Trial Master Files and other documents, contribute to guidelines and Standard Operating Procedures related to the topic (establishment and maintenance of regulatory and company requirements)
• Act as the backup person for the archiving lead as contact person for external logistics partner and management of their activities
• Coordinate timely retrieval of documents from the external archiving facility upon requests (e.g. for submissions and inspections)
• Provide guidance to internal and external stake holders (e.g. study managers/vendors) on Trial Master File archiving processes
• Support the archiving lead in the provision of quality management guidance on surveillance activities for vendor managed TMFs for the trial teams
• Health care education (e.g. nursing degree) in combination with the appropriate experience and demonstrated expertise in the clinical research environment
• Minimum of 4 years of experience in a clinical research administration/coordination or similar function including hands on experience relating to the essential documentation of a clinical trial
• Computer skills including using Database programs (e.g. eTMF)
Proven experience in working in a high volume environment handling multiple tasks
• Understand the regulatory and legal requirements for archiving across the major Geographic’s
• Fluency in English
• Position requires both domestic and international travel up to 5% of time
Please forward your application to Tom Sander (email@example.com) or www.randstad.de with the reference number 150673. If you have any further questions please do not hesitate to contact Mr. Tom Sander.
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