Job Description
We are looking for an experienced Business Analyst with strong expertise in Veeva CTMS and Clinical Trial Management processes. The ideal candidate should have hands-on experience in Veeva CTMS implementation, migration, and enhancement projects, along with strong skills in requirement gathering, functional documentation, stakeholder management, and clinical operations workflows.
The candidate will work closely with business stakeholders, clinical operations teams, and technical teams to deliver effective Veeva CTMS solutions.
Key Responsibilities
Gather, analyze, and document business requirements from Clinical Operations and other stakeholders.
Conduct requirement workshops, gap analysis, and impact assessments.
Prepare BRDs, FRDs, user stories, functional specifications, and process flow diagrams.
Work extensively on Veeva CTMS functionalities and clinical trial management workflows.
Coordinate with technical teams for Veeva CTMS configuration and implementation.
Support Veeva CTMS implementation, migration, and enhancement projects.
Manage change requests and provide functional support for production issues.
Support integrations between Veeva CTMS and other clinical systems, including EDC and eTMF.
Prepare and review test cases and support SIT, UAT, and functional testing.
Manage defects, coordinate resolutions, and support deployment activities.
Ensure compliance with GxP, GCP, and applicable regulatory requirements.
Collaborate with business and technical stakeholders to ensure successful project delivery.
Required Technical Skills
Minimum 3+ years of hands-on experience in Veeva CTMS.
Strong understanding of Clinical Trial Management processes.
Previous experience in Veeva CTMS implementation or migration projects.
Experience with Veeva Vault Clinical applications.
Knowledge of integrations between CTMS, EDC, eTMF, and other clinical systems.
Strong experience in requirement gathering, BRD/FRD preparation, and user story documentation.
Experience in Clinical Operations and clinical study workflows.
Understanding of ICH-GCP, GxP, and 21 CFR Part 11.
Experience in UAT, functional testing, and defect management.
Familiarity with Agile/Scrum methodologies, Jira, and Confluence.
Strong stakeholder communication and coordination skills.
Clinical Domain Knowledge
Candidates should have a good understanding of the clinical trial lifecycle, including:
Clinical Study Planning
Site Selection
Site Activation
Clinical Trial Monitoring
Study Management
Study Closeout
Preferred Candi