eTMF Administrator, Clinical Compliance Specialist

Summary

Join DELFI Diagnostics, a company developing next-generation blood-based cancer detection tests, as a Staff Specialist, Clinical Development Functional Excellence. Partner with Clinical Development study teams and key stakeholders to maintain eTMF and other clinical systems. Optimize Clinical Development processes, track compliance and training, develop and report KPIs/metrics, and ensure audit readiness. Report to the Vice President, Clinical Development. This role requires managing the eTMF system, collaborating with IT teams on system upgrades, developing eTMF workflows, overseeing training, tracking KPIs, and leading process development. You will also evaluate policies and procedures, partner with Clinical Quality Assurance, support system selection, and serve as a subject matter expert on clinical trial regulations. The position offers a competitive salary and benefits package.

Requirements

• Bachelor's degree or equivalent combination of education/experience in life science, health care or health-related field
• 8+ years of clinical research experience with at least 3 years in a medical device or IVD company
• 3+ years of experience with eTMF systems (eg, Veeva Vault, TransPerfect Trial Interactive, ClinEvo or similar systems)
• Proficiency in regulations governing the conduct of clinical studies including 21CFR812, ICH-GCP, ISO14155 and ISO20916
• Experience supporting and responding to internal audits and regulatory inspections
• Proven ability to collaborate cross-functionally, coach colleagues and identify fit-for-purpose, compliant solutions
• Excellent attention to detail, organization and communication skills

Responsibilities

• Serve as primary administrator for Clinical Development’s eTMF system, managing user access, roles, and permissions. Serve as the liaison between users and the eTMF vendor
• Collaborate with Software Engineering and IT teams to implement eTMF system upgrades, migrations and integrations with other clinical systems through the Change Control process
• Develop and implement eTMF workflows that align with clinical trial processes. Prepare document indexes mapping study records to their eTMF location based on the TMF Reference Model or study-specific requirements
• Oversee training activities including tracking compliance, training matrix development, preparation of training materials, conducting training and competency assessments as needed
• Be responsible for tracking and reporting of key performance indicators on Clinical Development studies, processes and clinical systems
• Lead the development, implementation, deployment and periodic review of standardized processes, templates, and training materials in collaboration with process owners across Clinical Development functions, including authoring SOPs and Work Instructions as directed
• Evaluate Clinical Development policies and standard operating procedures, identifying opportunities to ensure consistency across clinical trials and improve operational excellence and efficiency
• Partner with Clinical Quality Assurance to ensure Good Clinical Practice and Good Document Practice compliance within Clinical Development, and support internal/external audit and regulatory inspection-readiness activities
• Support evaluation and selection of new Clinical Development systems in collaboration with Clinical Development Leadership and other key stakeholders, as needed
• Be a subject matter expert within Clinical Development regarding regulations governing clinical trials
• Other duties as assigned by supervisor
• Developed a strong partnership with Clinical Quality Assurance and Software Quality Assurance
• Developed a thorough understanding Clinical Development systems, policies and procedures, identifying current compliance risks and opportunities for improvement
• Partnered with Clinical Quality Assurance to develop and implement DELFI’s strategy to ensure inspection-readiness of DELFI’s clinical study programs
• Under the guidance of the Vice President, Clinical Development, develop a roadmap to improve Clinical Development functional excellence

Preferred Qualifications

• Experience with system validation processes
• Experience building new Clinical Development operational processes in a start-up environment
• Experience in authoring SOPs
• Experience in Clinical Operations study oversight and execution
• Previous experience in the evaluation of IT systems supporting clinical study management, such as eTMF, CTMS, Document Control or EDC

Benefits

• $135,000 - $170,000 a year
• The total compensation for this role includes salary, bonus, equity, and benefits