EClinical Consultant, Migration Lead

Join the Just in Time GCP Team!

At Just in Time GCP, we simplify clinical compliance to clear the path forward for biotech and pharma sponsors. Our work helps organizations meet GCP expectations with confidence so that compliance never slows down progress. We're currently looking for an eClinical Consultant, Migration Lead to join our team of experts delivering high-quality support excellence across the life sciences industry.

In this role, you'll contribute to our mission of helping clients build strong, inspection-ready systems and processes. As an eTMF Migration Lead, you will play a critical role in helping clients transition TMFs with confidence while maintaining inspection readiness and data integrity.

• Lead end-to-end eTMF migration initiatives, primarily within Veeva Vault eTMF, including migration strategy, planning, execution, and closeout.
• Serve as the primary subject matter expert for eTMF migrations, advising clients on best practices, risk mitigation, and inspection readiness throughout the migration lifecycle.
• Conduct current-state and future-state TMF assessments, including structure, metadata, document quality, and completeness.
• Develop and execute migration strategies, including content mapping, taxonomy alignment, artifact reconciliation, and TMF Reference Model alignment.
• Lead or support migration validation activities, including validation plans, protocols, test scripts, execution, deviation management, and summary reports.
• Facilitate client workshops and working sessions focused on migration readiness, cutover planning, reconciliation, and post-migration quality checks.
• Partner closely with Veeva, migration vendors, and client stakeholders to ensure alignment on scope, timelines, deliverables, and quality expectations.
• Oversee and support User Acceptance Testing (UAT) and post-migration verification to confirm completeness, accuracy, and regulatory compliance.
• Ensure all migration activities comply with GCP, 21 CFR Part 11, Annex 11, and internal SOPs.
• Prepare and review high-quality consulting deliverables, including migration plans, SOPs, work instructions, training materials, and inspection-ready documentation.
• Mentor junior consultants and contribute to internal knowledge sharing around eTMF migration best practices.
• Support business development efforts by contributing migration expertise to proposals, solution design, and client discussions.

You’ll thrive in this role if you are detail-driven, confident leading complex migrations, and comfortable advising clients in regulated environments. We’re looking for someone who brings a combination of expertise, initiative, and collaboration.

• Bachelor’s degree in Life Sciences, Information Systems, or a related field (required).
• 5+ years of experience in eTMF operations, implementation, or migration, with a strong consulting or sponsor-side background.
• Hands‑on experience leading eTMF migrations, including legacy system to Veeva Vault transitions.
• Veeva Vault eTMF Certification (required).
• Deep understanding of the TMF Reference Model, TMF completeness, quality, and inspection readiness expectations.
• Proven experience with migration validation, including execution of validation documentation and testing activities.
• Strong working knowledge of GCP, 21 CFR Part 11, and Annex 11.
• Demonstrated ability to lead client workshops, manage cross‑functional stakeholders, and coordinate with vendors.
• Excellent analytical, organizational, and communication skills, with the ability to translate complex migration activities into clear, client‑ready deliverables.
• Proficiency in Microsoft Office, including preparation of polished presentations, trackers, reconciliation reports, and executive summaries.
• Ability to work independently while collaborating effectively within cross‑functional project teams.
• Client‑facing confidence with a consultative mindset and commitment to high‑quality outcomes.

At Just in Time GCP, we take pride in knowing our work helps bring safe, effective treatments to patients faster. Our team operates in a dynamic,…