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Clinical Project Support Specialist
hace 2 meses
This role is designed to provide comprehensive operational support to the global study team, ensuring the smooth execution of phase I-IV clinical trials.
Main Responsibilities- Administrative Support:
• Create and maintain different study documents and tools to support all different roles of the study.
• Update study Q&A and Action log.
• Set-up and maintain different project and study platforms/software. - 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. - Operating Trackers/Reports:
• Maintain different study trackers to keep study information up to date and ensure study oversight/quality at different study levels. - System Management:
• Upload/file/review different study level documents in eTMF and provide updates/reports on eTMF status. - Vendor/CRO Handling:
• Support outsourced studies, maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed.
The clinical development study and project coordination activities are accomplished through a strong skillset, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.
Bachelor's degree or equivalent in a relevant field with 1+ year of experience in clinical research/development ideally in the pharmaceutical industry.
Candidate ideally brings experience working with VEEVA System.
The incumbent must have the ability to manage multiple high-level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques and technology, have excellent knowledge of all Microsoft Office programs, and strong prioritization skills.
The incumbent must display excellent planning and organizational skills, innovativeness, and keen attention to detail and excellent follow through.
The incumbent must have strong interpersonal, communication and team working skills and must be able to manage high-level professional relationships with internal and external customers, like international teams, 3rd parties and people in a global environment.
Excellent communication and interpersonal skills, with fluency in English (both written and oral). Additional language skills are a plus.
