Clinical Project Support Specialist

hace 2 semanas

Barcelona, Barcelona, España Bayer A tiempo completo
Clinical Project Support Specialist

Bayer is a leading life science company that is committed to making a positive impact on people's lives. We are seeking a highly skilled and motivated Clinical Project Support Specialist to join our team.

Job Summary

The Clinical Project Support Specialist will provide comprehensive operational support to the global study team, ensuring the smooth execution of phase I-IV clinical trials. This role is pivotal in optimizing study efficiency, compliance, and quality, contributing to the timely regulatory submissions and market approval of new medicines and medical devices.

Key Responsibilities
  • Administration & Logistics: Create and maintain different study documents and tools, manage Study Contact Lists, update study Q&A and Action log, and oversee QSD tracker.
  • EU - CTR: Support EU-CTR transition and all study submissions.
  • Meeting support & communication: Act as a Study Team key contact, support Clinical/Study Team members with ad hoc tasks, and organize virtual/on-site Investigator meetings/Monitor meetings/Study Team meetings.
  • Operating trackers/reports: Maintain different study trackers, create study specific reports, and provide updates/reports on eTMF status.
  • System management: Upload/file/review different study level documents in eTMF, provide updates/reports on eTMF status, and maintain oversight of eTMF quality/completeness.
  • Vendor/CRO handling: Support outsourced studies, maintain oversight of CRO eTMF, and manage requests for different study materials.
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.
  • Ability to manage multiple high-level parallel tasks, work unsupervised, and possess excellent computer skills.
  • Excellent knowledge of all Microsoft Office programs, strong prioritization skills, and high level of flexibility.
  • Excellent planning and organizational skills, innovativeness, and keen attention to detail.
  • Strong interpersonal, communication, and team working skills, with fluency in English (both written and oral).
About Bayer

Bayer is a global life science company that is committed to making a positive impact on people's lives. We are a leader in the fields of healthcare, agriculture, and materials science. Our employees are passionate about making a difference and are driven by a shared purpose to improve people's lives.

We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, or any unlawful criterion under applicable law.

We are committed to treating all applicants fairly and avoiding discrimination.

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