Clinical Trial Associate

Job content

About the Company

A Global Pharmaceutical company

About the Role

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.

Responsibilities

• Trial Master File (TMF) & Documentation
• Contribute to the development of TMF plans where relevant.
• 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)
• Support study set-up activities in the organisation’s CTMS platform.
• 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.
• Study Support & Stakeholder Coordination
• Serve as a liaison among study teams, CROs, clinical experts, quality representatives, and legal teams regarding informed consent and other study documentation.
• Assist with tasks related to Clinical Outcome Assessments (COA), collaborating with internal and external partners.
• Manage administrative processes such as Letters of Authorization (LOA), Delegation of Authority (DOA), and Power of Attorney (POA).
• Oversee Activity Notification Forms (ANF), including reconciliation, coordination of study-specific activities, and e-payment requests.
• 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.
• Assist with audits or regulatory inspections, ensuring follow-up actions are completed promptly.
• Support the adoption and integration of new technologies and systems used in clinical operations.
• Operational Participation
• 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., HGRAC submissions for China or safety information coordination for Japan).
• Participate in internal process improvement initiatives.
• Perform additional tasks as assigned.
• Occasional travel may be required.

Qualifications

• Bachelor’s degree or equivalent experience in a clinical, scientific, or related field.
• Prior experience in clinical development is preferred, particularly in study start-up or documentation activities.
• NOTICE PERIODS OF MAXIMUM 1 MONTH
• Ability to adapt and work effectively in a fast-moving environment.
• Strong analytical thinking with the ability to challenge existing processes constructively.
• Skilled at building communication bridges with internal and external stakeholders.
• 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.
• High attention to detail and strong organisational abilities.
• Proficiency with Microsoft Office and willingness to learn new tools.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory frameworks (FDA, EU, etc.).
• Basic understanding of medical terminology and financial processes related to study activities.

Preferred Skills

• Comfortable managing multiple concurrent assignments.
• Able to work independently while contributing effectively to a global, cross-functional team.