Global Clinical Trial Assistant/Poland (Warsaw)

Description:

• * Assist in study specific document management, including finalization, distribution, and document revision management and archiving.
• * Assist in ancillary supply management, including ordering, distribution, and tracking.
• * Ensure the current study status and tracking of trial related information is available at all times in the appropriate clinical trial management system(s) (CTMS). Work with CRO, Local Trial Managers and Site Managers to ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial.
• * Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to agree upon timelines/milestones.
• * Responsible for review/management of Trial Master File (TMF) for completeness and timely provision of TMF content across all GCDO functions.
• * Support running GCDO dashboards & metrics reports with option to provide status analysis.
• * Coordinate and participate in internal and external study specific meetings, as necessary, and document outcomes, actions, and decisions.
* Follow-up to resolution when required.
• * Support medication related activities e.g. shipment tracking for non IWRS trials, coordination of relabeling, recall, product quality compliant, TMEQ, and TOR management and follow-up.
• * Support quality oversight and inspection readiness activities.

Profile:

*• At least 6 months of experience in clinical trials as Study Coordinator or on the similar position
* Excellent organization skills
*• Excellent written and verbal communication skills.
*• Excellent independent time management skills.
*• Proven ability to plan and track deliverables and timelines.
*• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
*• Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD