Clinical Project Support Specialist
hace 4 semanas
At Bayer, we're driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities, and redefining 'impossible'.
The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to the global study team. This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational support on a global level.
Key Responsibilities
**Administration & Logistics**
* Create and maintain different study documents and tools to support all different roles of the study.
* Create, maintain, and manage multiple study contact lists, including study/clinical team, vendor/external suppliers, and study organizations in Veeva.
* Update study Q&A and action log.
* QSD tracker oversight (ensure that QSD list is available at certain, required timepoints).
* Set up and maintain different project and study platforms/software, including SharePoint/TEAMS and OneNote.
**Study Contact Lists & QSD Tracker**
* 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 to set up and manage clinical/study team and steering committee meetings, including preparing, drafting, presenting slides, recording, taking minutes, and attendees list.
* 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 to ensure study oversight/quality at different study levels, including vendor trackers and logistics.
* Create study-specific reports, including CART, Veeva, IRT, etc.
* Create and update other team study-specific trackers that cannot be pulled from existing systems.
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