Ass C Clinical Quality Mgr
Athens, Greece
πριν από 4 μέρες

Job Overview :

Our FSP team is looking for a Quality Assurance Specialist to join our a sponsor dedicated positions based in Athens.

  • Responsibility for the annual country specific QC plan, monitoring, and coordinating the
  • implementation, and execution of QC plan in the respective country / US region according to the

    Client Standard Operating Procedures and ICH Guidelines and GCP

  • Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of
  • GCP audits and inspections in the country / US region at the Client level according to the Client

    Standard Operating Procedures and ICH Guidelines and GCP

  • Responsibility for the annual country specific quality plan, monitoring, and coordinating the
  • implementation and execution of QC in the respective country / region

  • Responsibility to manage and / or co-lead key Client initiative charged with executing the
  • continuous improvement.

  • ACCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
  • The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
  • This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client
  • Education / Qualifications :

  • University / college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
  • In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
  • Thorough understanding of the drug development process
  • Fluent in local office language and in English, both written and verbal
  • Experience :

  • Minimum of four-six (4-6) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
  • Deep knowledge and understanding of Clinical Trial processes and quality management tools

    Demonstrated experience leading cross-functional teams of business professional

    Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results

    Excellent site monitoring skills

    Excellent study site management skills

    Ability to work with minimal supervision

    Good planning and organization skills

    Good computer skills with good working knowledge of a range of computer packages

    Excellent verbal and written communication skills

    Ability to train junior staff

    Ability to resolve project-related problems and prioritizes workload for self and team

    Ability to work within a project team

    Works efficiently and effectively in a matrix environment

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