Standort: Vienna, Austria
Art: Vollzeit
Firma: PPD, part of Thermo Fisher Scientific
Eingetragen am: 2022-11-24

We are looking for a Clinical Trial Start Up Associate/ Country Approval Associate to join our team in Austria. In this position you will be home-based and will be responsible for optimizing country strategies and ensure compliance with local requirements for the DACH region.

Key Responsibilities

  • Prepare, review, compile and submit regulatory application dossiers to relevant institutions (Competent Authorities, Ethic Committees, etc.) in DACH region and act as a key contact, provide local expertise
  • Manage clinical trial projects under guidance and lead local teams to achieve goals/milestones, work with international team to maintain timelines for start-up activities in alignment with global strategy
  • Identify and escalate risks, develop proactive solutions to challenges
  • Maintain trial status information in databases (filing, tracking of trial related documents)
  • Gain and maintain knowledge of SOPs (standard operating procedures) and current regulatory regulations and guidelines in DACH region

Job Qualification

To be considered for this exciting opportunity, you will have the following:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Effective communication skills (verbal and written) in German and English
  • Excellent time management, planning and prioritization skills
  • Ability to work in a team environment or independently
  • Proactive and self-reliance working behavior
  • Outstanding negotiation and interpersonal skills
  • Fast decision-making ability and result oriented approaches
  • Strong attention to detail
  • Creative, flexible, agile working attitude
  • Ability to work well under pressure, managing multiple tasks and handle sensitive information with a high degree of confidentiality
  • Good IT skills and ability to learn appropriate software
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