Senior Clinical Trial Assistant
Reference Number: 895060-W
Type of placement: Contract, 12 months
Location: Switzerland, North West
Our client is a global pharmaceutical company focused on the treatment of critical care patients through the delivery of innovative, cost-effective medicines. For its office in Zurich we are looking for a flexible and dynamic Clinical Trial Assistant, who will be able to support global teams with all administrative tasks necessary for the running of global studies.
Qualifications and Experience:
- Support to CRO & Regional Operational Lead for US regions
- Supporting Clinical Operations and Finance on patient payment timelines, processing, QC and mailing of monthly payment cycles and responding to site inquiries regarding payments
- Logging, tracking and archival of Regulatory Documents
- Project CTMS - Entering Regulatory Files into the Clinical Trial Management System (CTMS) to meet roll-out timelines
- Trial Master File archival and maintenance (familiarity with required contents per the regulations & ICH guidelines to periodically assess completeness)
- Website communications and content management.
- Preparation and coordination of mail merges and mass shipments to sites.
- Maintenance of weekly team meeting minutes (draft, route for review, revise, distribute final to team and archive).
- Coordination of study material production (printing, design and cost approval, targets for distribution to sites, etc.)
- Prepare & send materials for Site Initiation Visits to sites
- Sending /tracking/filing CDAs and sending Regulatory Packages to new sites
- Maintenance of master study status lists and investigator and trial staff contact information (e.g., site activation and enrollment tracking lists or database(s), master contact lists, IVRS user lists, etc.)
- Coordinating distribution of expedited Safety reports & confirming site receipt of those reports
- Bachelor’s of Science degree preferred
- 5-6 years of Clinical Trials experience of which 4 years experience as CTA or similar
- Strong Project Management skills and ability to work independently
- Excellent communication and organization skills
- Fluent in both written and spoken English
- Relevant working/residency permit or Swiss/EU-Citizenship required