Clinical Trial Associate

Summary

The Clinical Trial Associate (CTA) plays a crucial support role for the SSO Study Start-Up Manager, Study Start-up CRA, and Clinical Research Associate across the entire study lifecycle, ensuring compliance with Novartis protocols, Good Clinical Practice (GCP), ICH guidelines, and regulatory standards.

Key Responsibilities

• Assist in the collection, preparation, and adaptation of documents required for Institutional Review Board (IRB), Ethics Committee (EC), and Health Authority submissions where relevant.
• Manage Investigator File (IF) and Trial Master File (TMF) at country and site levels, ensuring proper setup, upkeep, oversight, and tracking consistent with regulatory and Novartis requirements.
• Support vendor onboarding processes when necessary.
• Verify completion of site "Green Light" documentation and collaborate with local Qualified Person(s) to ensure all paperwork is in place for initial and ongoing drug release.
• Help prepare and translate Informed Consent Forms (ICFs) into local languages, including managing vendors if needed.
• Ensure comprehensive uploading of trial-related documents into the TMF, alongside managing archiving of physical TMFs.
• Contribute to the country-specific study start-up (SSU) strategy in close cooperation with SSU Team Lead and Managers, ensuring adherence to timelines and contractual commitments.
• Maintain compliance with financial regulations, applicable laws, ICH/GCP guidelines, IRB/IEC and Health Authority mandates, and Standard Operating Procedures (SOPs).
• Provide logistical support to SSU CRA, CRA, Clinical Project Manager (CPM), and SSU Manager throughout all clinical trial phases.
• Implement innovative and efficient process improvements aligned with Novartis’ strategic goals.

Essential Qualifications and Experience

• Degree or equivalent qualification in scientific, medical, or related discipline, complemented by at least one year of clinical operations exposure.
• Fundamental understanding of clinical drug development, with emphasis on study start-up, submission processes, and contracting workflows.
• Sound knowledge of ICH/GCP principles, IRB/IEC, and Health Authority requirements, ensuring daily compliance.
• Experience supporting maintenance, preparation, tracking, and completeness of regulatory documents and TMF to guarantee audit readiness.
• Ability to facilitate IRB/EC and Health Authority submissions by preparing and adapting relevant documents.
• Competency in managing study systems such as document repositories and tracking tools to ensure timely and accurate uploads.

About Novartis

Novartis is dedicated to supporting patients and their families by combining innovative science with a community-driven approach. Our culture encourages collaboration, mutual support, and inspiration to foster breakthroughs that significantly improve patient outcomes. We invite you to join us in building a brighter future together.

Benefits and Rewards

Discover numerous opportunities for personal and professional growth and support designed to help you thrive. A comprehensive employee handbook detailing these benefits is available for review.