Clinical Operations Specialist

hace 1 semana

Madrid, Madrid, España Pharmiweb A tiempo completo

Job Summary:

We are seeking a highly skilled Clinical Operations Specialist to join our team. As a key member of our clinical operations team, you will be responsible for supporting the delivery of clinical trials globally.

Key Responsibilities:

  • Support the clinical trial team at the global level, ensuring the successful delivery of projects.
  • Stay up-to-date with all changes and required knowledge on ICH GCP, sponsor's written standards, and attend relevant training sessions.
  • Manage study trackers and access, analyzing various reports, and distributing dashboards and reports to the study team in a timely manner.
  • Provide system-related support, including managing study systems, TMF management and maintenance, and providing timely follow-up with stakeholders to improve TMF compliance.
  • Work closely with the study team to manage activities post-SAC and till final archival.

Requirements:

  • Excellent technical/IT skills, with the ability to understand the impact of technology on studies and use and develop computer skills while making appropriate use of sponsor's systems/software.
  • Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
  • Able to work independently as well as in a team, with a professional attitude and good customer focus (internal and external).
  • Very good communication skills, with a 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 We Offer:

  • A competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, and competitive retirement planning offerings.
  • A 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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