Clinical Trial Associate - TMF Veeva

Position Summary

This fully remote contract opportunity is ideally suited to candidates located on the East Coast of the United States. The role focuses on supporting clinical operations by managing and overseeing vital documentation within the Trial Master File (TMF) using Veeva Vault. Candidates with prior experience interfacing with both Contract Research Organizations (CRO) and sponsor organizations are preferred.

Key Responsibilities

• Manage and maintain TMFs for clinical trials by receiving, reviewing, performing quality control, tracking, and archiving essential documents according to SOPs and regulatory standards.
• Ensure TMFs remain fully compliant and ready for inspections during the study lifecycle.
• Generate and share TMF-related metrics with internal teams and external partners.
• Collaborate interdepartmentally to support the implementation of the TMF oversight strategy.
• Create and maintain tracking tools monitoring patient enrollment, site activation, monitoring visits, and site payment processes.
• Assist in monitoring the performance of CROs and external service providers, including participation in Clinical Trial Working Group discussions.
• Evaluate monitoring visit reports to facilitate efficient study management.
• Review site-specific informed consent forms for accuracy and regulatory adherence.
• Oversee site feasibility questionnaires to support trial planning.
• Support the organization and coordination of Clinical Operations meetings and study-related events.
• Reconcile invoices with study contracts and budgets, aiding in site payment procedures.
• Prepare and circulate various trial communications such as newsletters and updates.
• Record and distribute meeting agendas and minutes related to clinical studies.
• Work closely with Clinical Trial Managers to prepare and maintain required study documents in compliance with protocols and regulatory requirements.

Qualifications

• At least two years of practical experience managing TMF content within Veeva Vault.
• Minimum of two years in clinical operations, preferably with experience spanning both sponsor organizations and CROs.
• Solid understanding of FDA regulations, ICH/GCP guidelines, and overall Good Clinical Practice standards.
• Experience collaborating with CROs and external vendors in clinical study execution.
• Proficiency in using Veeva Vault TMF and Microsoft Office suite, including Word, Excel, PowerPoint, and Smartsheet.
• Ability to manage shifting priorities in a fast-paced environment.
• Strong organizational skills, keen attention to detail, and excellent time management.
• Superior verbal, written, and interpersonal communication abilities.
• Bachelor's degree preferred, preferably in life sciences, healthcare, or a related field.