Clinical Data Services Associate - Clinical eTMF Management

Why This Role Matters
Clinical trials are the backbone of medical research, generating the evidence necessary to demonstrate the safety and efficacy of new therapies. Accurate and timely clinical data management is critical to ensure compliance with regulatory requirements, maintain trial integrity, and support decision-making for patient safety and treatment effectiveness. The Clinical Data Services Associate role in Clinical eTMF (electronic Trial Master File) management ensures that all trial documentation is properly collected, organized, verified, and maintained. By guaranteeing data quality and regulatory readiness, this position directly contributes to the success of clinical trials and the advancement of medical research.

Job Description
The Clinical Data Services Associate will join the Life Sciences R&D vertical at Accenture. This position focuses on Clinical Data Services, specifically Clinical eTMF management, supporting biopharma clients in ensuring high-quality trial documentation and regulatory compliance. The associate will manage, review, and validate clinical trial documents, ensuring adherence to internal standards and regulatory guidelines. This role provides exposure to the entire clinical trial lifecycle, including protocol packages, essential documents, trial master file checklists, and clinical study report appendices.

Key Features of the Role:
• Full-time position within Accenture Life Sciences R&D
• Exposure to global clinical trial processes and regulatory standards
• Work with leading biopharma clients across multiple therapeutic areas
• Opportunity to develop specialized skills in Clinical Data Services and eTMF management
• Gain expertise in quality review, documentation reconciliation, and compliance processes

Responsibilities:
• Perform TMF Quality Review for in-licensed Trial Master Files at all levels under the guidance of the TMF Manager
• Conduct data review and accuracy checks for the trial master file table of contents, initial full protocol packages, amended FPP checklists, and end-of-trial checklists
• Reconcile essential documents and ensure completeness of clinical study report appendices
• Collaborate with multiple stakeholders, including clinical operations, project managers, and regulatory teams, to resolve discrepancies and ensure compliance
• Support the management and tracking of clinical documents in eTMF systems
• Assist in audits and inspections by ensuring proper documentation and adherence to regulatory requirements
• Establish strong client relationships and effectively communicate findings and updates
• Manage multiple studies and tasks, prioritizing deadlines and performing under pressure

Required Qualifications:
• Bachelor’s degree in Life Sciences or related field
• 0 to 2 years of experience in clinical data management or clinical operations support, preferably in a Life Sciences/biopharma environment
• Knowledge of clinical trial documentation, trial master file standards, and regulatory compliance requirements

Skills Required:
• Strong attention to detail and analytical skills
• Ability to manage multiple stakeholders and handle disputes
• Excellent organizational skills and ability to meet deadlines under pressure
• Effective communication and interpersonal skills to work with clients and internal teams
• Basic familiarity with electronic TMF systems and clinical documentation processes

Experience and Skills:
Candidates should demonstrate the ability to perform quality review of trial documents, ensure accurate recordkeeping, and support regulatory compliance. Familiarity with clinical trial lifecycle and eTMF systems is preferred. Strong client-facing skills and problem-solving abilities are essential to manage expectations and resolve issues efficiently.

Company Overview:
Accenture is a global professional services company offering digital, cloud, and security solutions. Operating across more than 40 industries, Accenture provides strategy, consulting, technology, and operations services, as well as Accenture Song. With 784,000 employees serving clients in over 120 countries, Accenture is committed to delivering innovative solutions and driving success for clients, communities, and stakeholders.

FAQs:
Who can apply?
• Candidates with a Bachelor’s degree in Life Sciences and 0–2 years of relevant experience

What skills are required?
• Clinical data management, TMF review, regulatory compliance, stakeholder management

Is this a client-facing role?
• Yes, the associate will interact with clients and internal project teams

What systems will be used?
• Electronic Trial Master File (eTMF) systems and other clinical documentation tools

Application Tips:
• Highlight any clinical data or trial management experience in your resume
• Emphasize attention to detail, organizational skills, and ability to work under deadlines
• Showcase experience with eTMF systems or clinical documentation standards
• Include examples of collaboration with multiple stakeholders in clinical projects