Clinical eTMF Management Associate - Clinical Data Services

Why This Role Matters
Clinical trials generate large volumes of essential documentation that must be carefully managed to ensure regulatory compliance and data integrity. The Trial Master File (TMF) is one of the most critical components of clinical trial documentation, as it provides a complete record of the study conduct and ensures that trials meet regulatory standards. As a Clinical Data Services Associate specializing in Clinical eTMF Management at Accenture, you will play an important role in maintaining the accuracy, completeness, and accessibility of clinical trial documents. Your work will support pharmaceutical and biotechnology companies in organizing and maintaining trial documentation throughout the lifecycle of a clinical study. By ensuring that all required documents are properly reviewed, reconciled, and stored in electronic Trial Master File systems, you help maintain transparency and compliance with global regulatory authorities. This role provides the opportunity to work at the intersection of clinical research, regulatory compliance, and data management while contributing to the success of clinical trials and the development of innovative treatments.

Job Description
The Clinical Data Services Associate will work within Accenture’s Life Sciences Research and Development vertical, specifically in the Clinical, Pharmacovigilance & Regulatory sub-offering. This role focuses on Clinical eTMF Management and involves supporting the organization, maintenance, and quality review of electronic Trial Master File documentation throughout the lifecycle of clinical trials. Employees in this role will be responsible for reviewing, managing, and reconciling essential documents within the electronic Trial Master File system. The position requires ensuring that all trial documentation is complete, accurate, and compliant with regulatory requirements and internal standard operating procedures. Activities include reviewing trial master file table of contents, validating document completeness, and performing reconciliation checks to ensure that all essential documents are properly archived. The role also involves working closely with clinical teams and stakeholders to manage document workflows, address documentation gaps, and ensure that regulatory expectations are met during different phases of the clinical trial. Employees are expected to manage multiple tasks, maintain strict timelines, and contribute to the efficient organization of regulated clinical trial content. This is an individual contributor role within a team environment where employees support global clinical research projects while maintaining high standards of data quality and compliance.

Key Features of the Role: Responsibilities
• Manage and maintain electronic Trial Master File documentation throughout the clinical trial lifecycle.
• Perform quality review and accuracy checks for trial master file table of contents and related documents.
• Review headquarters documentation and ensure correct filing of essential clinical trial documents.
• Validate initial full protocol package and amended protocol package documentation.
• Conduct end-of-trial checklist reviews to ensure completeness of documentation.
• Perform essential document reconciliation to identify missing or incomplete records.
• Support the preparation and maintenance of clinical study report appendices.
• Coordinate with clinical teams and stakeholders to resolve documentation gaps or discrepancies.
• Ensure compliance with regulatory guidelines and internal standard operating procedures.
• Maintain accurate tracking of TMF documentation and ensure timely updates within the system.

Required Qualifications
• Bachelor of Science (BSc) in Life Sciences, Biotechnology, or related field.
• 1 to 3 years of experience in clinical research operations, clinical documentation, or data management.
• Basic understanding of clinical trial processes and regulatory documentation requirements.
• Strong attention to detail and ability to manage structured documentation processes.
• Ability to work effectively in a team environment and collaborate with multiple stakeholders.
• Adaptability and ability to perform under pressure while meeting deadlines.

Educational Requirements
• Bachelor’s degree in Life Sciences or related scientific discipline.
• Knowledge of clinical research documentation and trial master file processes is advantageous.
• Familiarity with electronic document management systems or eTMF platforms is beneficial.

Experience and Skills
• 1 to 3 years of professional experience in clinical data services, clinical research operations, or documentation management.
• Experience working with electronic Trial Master File systems or document management platforms is preferred.
• Strong organizational skills to manage large volumes of clinical documentation.
• Ability to coordinate with cross-functional teams and manage multiple stakeholders.
• Effective problem-solving skills to identify documentation issues and ensure timely resolution.
• Strong communication skills and ability to work under strict project timelines.

Salary Insights
• Competitive salary based on experience and industry benchmarks.
• Additional benefits may include health insurance, learning and development opportunities, and performance-based incentives.

Company Overview
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With more than 784,000 employees serving clients in over 120 countries, the company helps organizations deliver innovation and value through advanced technology and human expertise. Within the Life Sciences R&D vertical, Accenture supports pharmaceutical and biotechnology companies with services including clinical trial support, pharmacovigilance, regulatory compliance, and patient services solutions. By combining scientific expertise with advanced technology platforms, Accenture helps organizations accelerate research, maintain regulatory compliance, and improve patient outcomes worldwide.

FAQs
• What is the main focus of this role?
The role focuses on managing electronic Trial Master File documentation and ensuring the completeness and accuracy of clinical trial records.

• What systems will be used in this role?
Employees may work with electronic Trial Master File platforms and document management systems used in clinical trials.

• Is collaboration required in this role?
Yes, employees coordinate with clinical teams and stakeholders to ensure that all trial documentation is complete and compliant.

Application Tips
• Highlight experience related to clinical research documentation, trial master file management, or data services.
• Mention familiarity with electronic document management systems if applicable.
• Emphasize organizational skills, attention to detail, and ability to meet deadlines.
• Tailor your resume to demonstrate knowledge of clinical trial documentation and regulatory compliance processes.