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Clinical Project Support Specialist

2 months ago

Mississauga, Ontario, Canada Bayer (Schweiz) AG Full time
About the Role

Bayer (Schweiz) AG is seeking a highly skilled Clinical Project Support Specialist to join our team. As a key member of our global study team, you will play a pivotal role in ensuring the smooth execution of phase I-IV clinical trials.

Key Responsibilities
  1. Administrative and Logistical Support
    - Develop and maintain comprehensive study documents and tools to support global study teams.
    - Manage multiple Study Contact Lists, including vendors, external suppliers, and study organizations in Veeva.
    - Oversee study Q&A and Action log updates.
    - Ensure timely QSD list availability.
    - Set up and maintain project and study platforms, including SharePoint and Teams.
    - Provide ad-hoc support to Clinical/Study Team members.
    - Support audits and inspections according to company policy and SOPs.
  2. EU-CTR Support and Study Submissions
    - Assist with EU-CTR transition and study submissions.
  3. Meeting Support and Communication
    - Serve as a key contact for eTMF Specialist/System Specialist.
    - Support the organization of Clinical/Study Team and Steering Committee meetings, including preparing, drafting, and presenting slides, recording, and taking minutes and attendees lists.
    - Assist with virtual and on-site Investigator meetings/Monitor meetings/Study Team meetings.
  4. Tracker and Report Management
    - Maintain study trackers to ensure oversight and quality at different study levels, including vendor trackers and logistics.
    - Create study-specific reports, such as CART, Veeva, and IRT reports.
    - Develop and update team-specific study trackers.
  5. System Management and eTMF Oversight
    - Upload, file, and review study-level documents in eTMF.
    - Provide updates and reports on eTMF status and maintain oversight of eTMF quality and completeness.
    - Support eTMF closure.
  6. Vendor and CRO Management
    - Support outsourced studies and maintain oversight of CRO eTMF and Veeva systems.
    - Manage requests for study materials not provided by central labs.
Requirements
  • Strong understanding of clinical development and global operating processes in drug development, as well as ICH-GCP and international regulations.
  • 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 highly desirable.
  • Ability to manage multiple high-level parallel tasks, work unsupervised, and possess excellent computer skills.
  • Strong prioritization skills, flexibility, and willingness to support the team.
  • 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.