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Clinical Project Support Specialist

hace 2 meses

Barcelona, Barcelona, España Mygwork A tiempo completo

About the Role:

The Clinical Project Support Specialist will play a pivotal role in ensuring the smooth execution of phase I-IV clinical trials by providing comprehensive operational support to global study teams. This role is crucial 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 to support various roles within the study.
    • Manage multiple Study Contact Lists: Study/Clinical Team, Vendor/External Suppliers, Study Organizations in Veeva.
    • Update study Q&A and Action log.
    • QSD tracker oversight to ensure timely availability of QSD lists.
    • Set up and maintain different project and study platforms/software, e.g., SharePoint/TEAMS, OneNote.
    • Support Clinical/Study Team members with ad-hoc tasks.
    • Support audits and inspections according to company policy and SOPs.
  • EU - CTR:
    • Support EU-CTR transition and all study submissions.
  • Meeting Support & Communication:
    • Act as a Study Team key contact with eTMF Specialist/System Specialist.
    • Support setting up and managing Clinical/Study Team and Steering Committee meetings, including preparing, drafting, presenting slides, recording, taking minutes, and attendees lists.
    • Support organization of virtual/on-site Investigator meetings/Monitor meetings/Study Team meetings.
  • Operating Trackers/Reports:
    • Maintain different study trackers to keep study information up-to-date and ensure study oversight/quality at various study levels, including vendor trackers and logistics.
    • Create study-specific reports, e.g., CART, Veeva, IRT.
  • System Management:
    • Upload/file/review different study-level documents in eTMF.
    • Provide updates/reports on eTMF status and maintain oversight of eTMF quality/completeness.
    • Support eTMF closure by ensuring availability of all documents uploaded to eTMF.
    • Manage user accesses for different study systems, including Bayer/vendor systems or updating information for vendor system access/portals.
  • Vendor/CRO Handling:
    • Support outsourced studies and maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed.
    • Manage requests for different study materials not provided by central labs/RR.
    • Coordinate logistics (orders, shipments, custom clearance) of trial supplies for sites.

Requirements:

  • Bachelor's degree or equivalent in a relevant field.
  • 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.
  • High level of flexibility, willingness to support the team, and ability to manage complexity.
  • Good analytical and problem-solving skills, excellent planning and organizational skills, innovativeness, and keen attention to detail.
  • Strong interpersonal, communication, and team working skills, with the ability to manage high-level professional relationships with internal and external customers.
  • Fluency in English (both written and oral) is required, with additional language skills a plus.