Remote - Trial Master File (TMF) Specialist

A highly reputable biotechnology corporation is currently hiring a Trial Master File (TMF) Specialist to work remotely in the United States.

Summary / Job Description:

• The TMF Specialist will support TMF-related activities in collaboration with the internal cross functions and manage documentation of files with CROs and TMF vendors according to study TMF plans.
• Accountable for the management of paper and electronic trial master files across clinical studies.
• Assist in the in-house TMF Operations to support Clinical Development.
• Collaborate with clinical study teams to manage study TMF plans and indexes with CRO partners and TMF vendor.
• Partner with cross-functions to ensure TMF quality, timeliness, and completeness throughout the lifecycle of the studies.
• Maintain TMF configurations, processes, procedures, and training materials that adhere to regulatory requirements.
• Manage the quality control of TMF documents according to GCP and regulatory requirements from study start up to study closeout/archival and preparation for inspections.
• Collaborate with clinical study teams to monitor TMF inventory lists, metrics, periodic TMF reviews according to study specific TMF plan, oversee KPIs, identify areas for improvements and develop change processes, as needed.
• Serve as eTMF business administrator, including monitoring the impact of configuration changes to optimize performance.
• Support TMF elements of regulatory inspections in providing relevant documents and responses, as needed.

Requirements:

• Bachelors in Life Sciences or advanced degree
• A minimum of 4 years of experience maintaining eTMF system(s)
• Must have experience with Veeva Vault system (eg, eTMF)
• Understanding and experience with TMF reference model and cross-functional clinical processes
• Excellent planning, organizational, and time management skills to support and prioritize multiple projects
• Must be self-motivated, able to evaluate and resolve complex problems, and adaptable to a dynamic fast-paced environment
• Expertise in quality and GCP requirements to ensure the organization remains compliant with ICH GCP and other global regulatory guidelines or laws
• Prior inspection readiness experience is highly desired
• Excellent written and verbal skills required