Clinical Project Support Specialist

hace 4 semanas


Barcelona, Barcelona, España Bayer A tiempo completo

Key Role Details

The Clinical Project Support Specialist plays a pivotal role in ensuring the smooth execution of phase I-IV clinical trials by providing administrative, logistical, and operational support on a global level.

This role is designed to optimize study efficiency, compliance, and quality, contributing to the timely regulatory submissions and market approval of new medicines and medical devices.

Key Responsibilities

  • Create and maintain different study documents and tools to support various roles within the study.
  • Update study Q&A and Action log.
  • Oversight of QSD tracker to ensure timely availability of QSD lists.
  • Set up and maintain project and study platforms/software.
  • Support Clinical/Study Team members with ad hoc tasks.
  • Support audits and inspections according to company policy and SOPs.
  • EU-CTR transition support and study submissions.
  • Meeting support and communication.
  • Operating trackers/reports.
  • System management.
  • Vendor/CRO handling.

Requirements

  • Bachelor's degree or equivalent in a relevant field with 1 year + of experience in clinical research/development ideally in the pharmaceutical industry.
  • Experience working with VEEVA System is a plus.
  • Ability to manage multiple high-level parallel tasks, work unsupervised, and have effective computer skills.
  • Excellent knowledge of Microsoft Office programs and strong prioritization skills.
  • Flexibility, willingness to support the team, and ability to manage complexity.
  • Excellent planning and organizational skills, innovativeness, and keen attention to detail.
  • Strong interpersonal, communication, and team working skills.
  • Fluency in English (both written and oral) with additional language skills a plus.


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