Clinical Project Support Specialist

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Clinical Project Support Specialist Position purpose

The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study team. This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational on global level. The incumbent will work closely with global study team members, and other key stakeholders on a global level to optimize study efficiency, compliance, and quality, contributing tothe timely regulatory submissions and market approval of new medicines and medical devices.

Geographical scope

Global

Legal entity

Euro services Bayer Major tasks of position

Administration & Logistics Create and maintain different study documents and tools (e.g., Study Guide documentation, different study instructions, study newsletters, financial disclosure summary tables, invoices) to support all different roles of the study.

Create, maintain, and 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 (make sure that QSD list is available at certain, required time points).Set-up and maintain different project and study platforms/ software e.g., SharePoint/TEAMS, One Note.

Support Clinical/Study Team members with one ad hoc time tasks.

Support audits and inspections according to company policy and SOPs.EU - CTRSupport EU-CTR transition and all study submissions

Meeting support & communication

Act as a Study Team key contact with eTMF Specialist / System Specialist.

-Support to set up and manage Clinical / Study Team and Steering Committee meetings e.g. preparing, drafting, presenting slides, recording, taking minutes and attendees list.

Support organization of virtual/on-site Investigator meetings / Monitor meetings / Study Team meetings (e.g., Start-Up Camps and KOMs, weekly Study Team meetings, CLM's meetings)
Contribute to departmental / company initiatives and special projects. Provide expertise and support project planning, project management and implementation of functional initiatives to improve processes.

Operating trackers/reports

Maintain different study trackers to keep study information up to date and to ensure study oversight/quality at different study levels, including vendor trackers and logistics (e.g., EPROtranslations, vendor manual, devices, lab kits etc.).Create study specific reports (e.g., CART, Veeva, IRT etc.)-Create and update other team study specific Trackers, that cannot be pulled from existing systems

System management

Upload/file/review different study level documents in eTMF (from StM & SLM, but also from other functions if agreed with the Team).Provide updates/reports on eTMF status (in Study Team meetings/country calls/regular communications) and maintain oversight of eTMFquality/completeness (if agreed with the Team and depending on which reports that are provided by eTMF Specialist).Support eTMF closure (e.g. by ensuring availability of all documents uploaded to eTMF).Maintain

IT systems list in Gemstone.

Manage user accesses for different study systems (Bayer/vendor systems or…