TMF Quality Specialist (Contract)
Core
QC review and oversight of Trial Master File (TMF) documentation to ensure compliance with GCP and regulatory standards for clinical trials.
Role type
Senior IC TMF Quality Specialist (Contract)
Builds
Inspection-ready TMF documentation and optimized eTMF workflows
Domain
Biotechnology / Clinical Trials / Regulatory Compliance
Required skills
TMF Operations, Veeva Vault eTMF, ICH GCP, CDISC Reference Model, Regulatory Documentation, CRO Management, System Reporting, Dashboard Development, Excel Proficiency
Preferred skills
Veeva Vault CTMS, Veeva Vault RIM, Clinical Trial Lifecycle Management
Responsibilities
Perform detailed QC reviews of TMF documents to verify metadata accuracy and compliance; Identify documentation gaps and collaborate to resolve them; Contribute to continuous improvement of Oversight Review processes within Veeva Vault eTMF; Assist in preparing business requirements and participating in validation testing from a Business Process Owner perspective.
Seniority
Senior, hands-on IC
