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Our client is looking to fill the role of CTA. The Senior Clinical Trial Associate supports the operational execution of clinical studies by partnering with internal Clinical Operations team, study sites, vendors, and CROs. This role is responsible for clinical trial documentation, tracking, vendor coordination, and study support activities to help ensure trials are conducted in compliance with applicable regulations and company procedures.
Job Responsibility
Support day-to-day clinical trial operations across one or more studies
Maintain and organize Trial Master File (TMF) documentation and track essential study records
Monitor document status and communicate outstanding items to the study team
Track study metrics, enrollment, site activity, and clinical supply information
Assist with vendor, CRO, and site coordination activities
Support invoice tracking, reconciliation, and study budget administration
Identify and communicate study issues, risks, or operational concerns to the clinical team
Assist with review and management of study-related documents and materials
Ensure compliance with applicable regulations, GCP guidelines, SOPs, and study requirements
Perform additional clinical operations activities as assigned
Requirements
Bachelor's degree in Life Sciences or a related field preferred
Minimum of 3 years of clinical operations or clinical trial support experience
Experience supporting clinical studies within the biotechnology, pharmaceutical, medical device, or CRO industry preferred
Autoimmune experience required
Working knowledge of clinical trial processes, documentation, and GCP requirements
Strong organizational skills with exceptional attention to detail
Proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint
Strong written and verbal communication skills
Ability to manage multiple priorities and work effectively in a collaborative environment