Clinical Project Support Specialist

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.

Global

Euro services Bayer

• Create and maintain different study documents and tools (e.g., Study Guide documentation, different study instructions, study newsletters, financialdisclosure 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.

• Support EU-CTR transition and all study submissions

• 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.

• 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., EPRO translations, 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

• 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 updating information for vendor system access/portals such as IRT, Central Lab, ePRO vendor, adjudication vendor, SharePoint restricted area, TEAMS channels).
• Maintain and update Veeva/Gemstone entries.
• Support VST transition (Veeva Study Training ) and request Training log annual update for Study Team Members.

• Support outsourced studies, 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 (bags, miniprotocols, manuals). Coordinate logistics (orders, shipments,custom clearance) of trial supplies for sites (e.g. eCOA device orders and shipments, laboratory kits, manuals, miniprotocols, medical equipments, RRmaterials
  -if requested)

Indivudal contributor

The CPSS will interact on a global scale within the study team and clinical team. The CPSS sphere of influence and communication will include the Study Manager(s), the Study Lead Monitor(s), Study Data Manager, Study Statistician, country teams, the IxRS & Medication Manager (IMM Legal,procurement, Pharmacovigilance, Insurance and other study team members (globally). Locally main contact are the Clinical Operations manager 3 and 4,Study manager and Study Lead monitors.

The CPSS will additionally liaise…