Clinical Operations Specialist

hace 4 semanas

Gasteiz Vitoria, Álava, España Pharmiweb A tiempo completo

Job Summary:

We are seeking a highly skilled Clinical Operations Specialist to join our team at Pharmiweb. As a Clinical Operations Specialist, you will play a critical role in supporting the clinical trial team at the global level, impacting the project's success.

Key Responsibilities:

  • Keeping up to date with all the changes and required knowledge on ICH GCP, sponsor's written standards, and attending appropriate training sessions.
  • Supporting multiple studies simultaneously and prioritizing appropriately to meet business needs to ensure delivery of results.
  • Management of access and study trackers.
  • Maintaining all the study trackers and access.
  • Analysis of various reports.
  • Timely distribution of dashboards and reports to the study team.
  • System related support.
  • Managing study systems.
  • TMF Management and Maintenance.
  • Managing TMF activities both for In-house and FSO trials.
  • Providing timely follow-up with the stakeholders to improve TMF compliance.

Requirements:

  • Excellent technical/IT skills.
  • Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of sponsor's systems/software.
  • Knowledgeable of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
  • Able to work independently as well as in a team.
  • Professional attitude with good customer focus (internal and external).
  • Time Management as system updates, eTMF, etc. need to be done in a timely manner.
  • Very good communication skills - high English level.
  • 1-2 years of prior experience in clinical operations as CTA, CPA, or similar.
  • Knowledgeable of main systems (vTMF, mCTMS) and the willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits.

Our benefits examples include:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.

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