About the Company A Global Pharmaceutical company
The Clinical Trial Associate (CTA) provides essential operational support to the Global Clinical Project Management function, helping ensure clinical studies are delivered on schedule and in compliance with quality, regulatory, and procedural requirements. The role contributes to the planning, set-up, execution, and completion of clinical trials across multiple regions.
Trial Master File (TMF) & Documentation
Conduct ongoing and final quality checks of TMF sections owned by the Clinical Project Manager (CPM).
Collaborate with Contract Research Organizations (CROs) to resolve documentation queries and ensure accuracy and completeness.
Use TMF dashboards and analytics tools to assess TMF health and identify improvement needs.
Clinical Trial Management Systems (CTMS)
Provide updates and information to maintain accurate data fields throughout the study lifecycle.
Perform periodic CTMS quality checks and coordinate issue resolution with CROs or CPMs.
Serve as a liaison among study teams, CROs, clinical experts, quality representatives, and legal teams regarding informed consent and other study documentation.
Manage administrative processes such as Letters of Authorization (LOA), Delegation of Authority (DOA), and Power of Attorney (POA).
Arrange shared digital workspaces and manage study-level access permissions where applicable.
Create and maintain study team lists, SOP inventories, and associated updates.
Compliance, Quality & Reporting
Request and review aggregate financial reports related to study activities; highlight significant payments and support documentation for compliance and bias mitigation.
Support the adoption and integration of new technologies and systems used in clinical operations.
Contribute as a member of Joint Clinical Study Teams and other trial-related forums.
Support CPMs with study-level planning, start-up, maintenance, and close-out activities when needed.
Manage region-specific responsibilities where applicable (e.g., Bachelor’s degree or equivalent experience in a clinical, scientific, or related field.
Capable of identifying efficiencies and contributing to portfolio delivery improvements.
Quick learner with the ability to master new systems and assist in training colleagues.
Excellent written and verbal communication skills in English; additional languages beneficial.
Proficiency with Microsoft Office and willingness to learn new tools.
Basic understanding of medical terminology and financial processes related to study activities.
Comfortable managing multiple concurrent assignments.
Able to work independently while contributing effectively to a global, cross-functional team.