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Job Summary:

We are seeking a highly skilled and proactive Veeva CTMS Subject Matter Expert (SME) to join our consulting firm and support our Life Sciences clients in optimizing clinical trial management processes. This role will be responsible for managing Veeva CTMS, eTMF, EDC implementations, ensuring compliance, and enabling efficient trial lifecycle management for our clients.

 

Key Responsibilities:

Act as the subject matter expert (SME) for Veeva CTMS, eTMF, and EDC across our Life Sciences consulting projects. Lead end-to-end configuration of Veeva CTMS, eTMF, and EDC to support clinical trial planning, execution, data management, and reporting for various clients. Manage stakeholder relationships with clients to gather requirements and implement platform enhancements that align with their clinical operation’s needs. Ensure compliance with regulatory standards and internal processes throughout the clinical trial lifecycle for client projects. Collaborate with cross-functional teams (Clinical Operations, Data Management, Regulatory, IT) within client organizations to optimize system usage and streamline workflows. Provide training and support to client end-users, ensuring the adoption of Veeva best practices in CTMS, eTMF, and EDC. Monitor system performance, troubleshoot issues, and manage vendor relationships to ensure optimal functionality for client implementations. Support audits and inspections by maintaining accurate documentation and audit trails for client projects.

 

Qualifications:

Bachelor’s degree in Life Sciences, Information Technology, or related field. 3–6 years of hands-on experience with Veeva CTMS, eTMF, and EDC in a pharmaceutical or life sciences consulting environment. Strong analytical and problem-solving skills. Understanding of clinical trial processes, data management, and regulatory compliance. Excellent communication, stakeholder management, and problem-solving skills.

 

Nice to Have:

Experience with other clinical trial management systems (CTMS), electronic data capture (EDC) platforms, or electronic trial master files (eTMF). Exposure to clinical trial optimization or digital transformation initiatives within consulting. Veeva certifications (CTMS, eTMF, EDC) are a plus.

 

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