Clinical Project Support Specialist

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Clinical Project Support SpecialistPosition purposeThe Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study team. This role is pivotal inensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational on global level. The incumbent will workclosely 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 scopeGlobalLegal entityEuroservices BayerMajor tasks of positionAdministration & LogisticsCreate 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 timepoints).
Set-up and maintain different project and study platforms/ software e.
G., SharePoint/TEAMS, OneNote.
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 submissionsMeeting support & communicationAct 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, takingminutes and attendees list.
Support organization of virtual/on-site Investigator meetings / Monitor meetings / Study Team meetings (e.
G., Start-Up Camps and KOMs, weekly StudyTeam meetings, CLM's meetings)Contribute to departmental / company initiatives and special projects. Provide expertise and support project planning, project management andimplementation of functional initiatives to improve processes.
Operating trackers/reportsMaintain different study trackers to keep study information up to date and to ensure study oversight/quality at different study levels, including vendortrackers 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 systemsSystem managementUpload/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, CentralLab, 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.
Vendor/CRO handlingSupport 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)Contribution contextIndivudal contributorWork interactionsThe CPSS will interact on a global scale within the study team and clinical team. The CPSS sphere of influence and communication will include the StudyManager(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 ma