Senior TMF Specialist - Remote Contractor Position

About the Role

We are seeking a Senior TMF Specialist - Remote to join our team as a contractor. In this role, you will oversee the management of Trial Master Files (TMF) ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. As a Senior TMF Specialist, you will play a crucial role in supporting clinical trials and ensuring data integrity.

What You'll Do

• Manage and maintain the Trial Master File (TMF) throughout the lifecycle of clinical trials.
• Ensure compliance with GCP and regulatory standards in all TMF activities.
• Collaborate with cross-functional teams to ensure timely and accurate documentation.
• Conduct quality control checks on TMF documents to ensure completeness and accuracy.
• Utilize Veeva Vault for document management and ensure proper version control.
• Provide training and support to team members on TMF processes and compliance.
• Participate in audits and inspections related to TMF documentation.
• Assist in the development and maintenance of TMF-related policies and procedures.

Requirements

• Minimum of 5 years of experience in TMF management or related field.
• Strong understanding of GCP, FDA regulations, and clinical trial processes.
• Experience with Veeva Vault or similar document management systems.
• Excellent organizational skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and manage multiple priorities.
• Proficient in Microsoft Office Suite.
• Experience in clinical research or regulatory affairs is a plus.

Nice to Have

• Experience with bioinformatics or R programming.
• Knowledge of pharmacovigilance and safety operations.
• Familiarity with vendor management and contract management.

What We Offer

• Competitive salary ranging from $90,000 to $120,000 annually.
• Equal Opportunity Employer committed to diversity and inclusion.
• Supportive work environment fostering professional growth.
• Flexible remote work arrangements.
• Opportunities for continuous learning and development.