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Clinical Compliance Manager

Város:  Budapest
Szakterület:  Természettudományok, Kutatás
Tapasztalati szint:  5+ év

Join us

​​​​​​Subject matter expert for clinical quality matters when collaborating with clinical / interdisciplinary teams and external partners in clinical development programs to take appropriate steps to ensure of quality goals and ongoing sponsor oversight responsibility

Your responsibilities

      • Act as liaison for the Clinical Development Teams with corporate quality functions including but not limited to Quality Assurance
      • Develop, implement, maintain and evaluate an effective quality assessment and performance improvement program(s) in alignment with other interdisciplinary team
      • Responsible for monitoring and updating policies and procedures (SOP) to include regulatory changes
    • Provide support and clear advice to the Clinical Development Teams on all aspects/issues that may have quality /GCP relevance :
    • Develop and implement measures to ensure adherence to critical sponsor oversight obligations
    • Contribute to development/adherence to all quality management documents/plans,
    • Proactive, continuous  and on-time quality monitoring to all aspects of quality oversight performed by the Sponsor
    • Identify potential or real quality issues including impact analyses, e.g., identification and assessment of PDs
    • Ensure that the all sponsor activity meet the expectations of GCP and regulatory authorities

Ensures appropriate Sponsor’s CRO management and oversight such as planning and contribution to internal and external GCP audits, oversee filing and maintenance of study/project documents

You bring to our team

  • Profound knowledge of ICH-GCP and proven track record of audit and inspection planning/preparation
  • Solid operational experience in Clinical Research for a minimum of 5 years on an international level
  • Team player with solid project management skills to lead assigned clinical trials as a member of an international project team
  • Excellent computer skills

Excellent oral and written communication skills in English

We offer

  • Extensive benefits package (cafetera, stock program, private life insurance)
  • Training and development opportunities
  • Medical services (Medicover) 
  • Various sport and health opportunities (gym, swimming pool, AYCM)
  • Challenging, responsible professional work
  • Long-term employment in an innovative and secure workplace

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