A dynamic biopharmaceutical company is seeking a Clinical Trial Associate (CTA) to support the Clinical Operations team across all aspects of study management. This role focuses on TMF oversight, clinical documentation, and day-to-day project coordination within a fast-paced, outsourced environment.
The organization is dedicated to developing innovative therapies for patients with rare diseases. Their mission is to deliver impactful treatments by running high-quality, patient-focused clinical trials with efficiency and precision.
Key Responsibilities
- TMF & Documentation: Manage eTMF setup, quality control, audit readiness, and archiving; support Sponsor oversight and documentation compliance.
- Clinical Support: Track study milestones, organize training records, assist with vendor coordination, meeting scheduling, and material distribution.
- Project Coordination: Provide administrative support to the Clinical team, take meeting minutes, and help ensure alignment with ICH-GCP and SOPs.
Key Requirements
- Experience: Previous experience in pharma/biotech; hands-on expertise with eTMF systems is essential.
- Skills: Strong organizational, multitasking, and communication skills; high attention to detail and proficiency in Microsoft Office and SharePoint.
- Attributes: Self-starter, adaptable, reliable, and able to work effectively in a small, collaborative team environment.
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