TMF Operations Leader - Records Management (Remote)

Scorpion Therapeutics; Hayward (CA); On-site; USD 155,000 - 170,000; Full time

Benefits offered by this job

Stock programs

Performance-based bonus

Comprehensive benefits

Job summary

Scorpion Therapeutics seeks an experienced TMF Operations Leader to oversee TMF program management, governance, and vendor oversight. You will drive standards, SOPs, and inspection readiness, ensuring compliant, scalable TMF processes across global studies.

Strong leadership and regulatory knowledge are essential. The role partners with IT to optimize Veeva eTMF and related systems, supports audits, and guides process improvements in a fast-paced environment.

Qualifications

• Bachelor’s degree required; scientific field preferred.
• 8+ years sponsor/CRO experience; 3+ years TMF management.
• Experience supporting audits/regulatory inspections (FDA, EMA, MHRA).
• Familiarity with ICH-GCP and TMF regulatory requirements.

Responsibilities

• Oversee TMF operations to improve functionality, efficiency, scalability and quality.
• Lead TMF vendor oversight and governance.
• Develop and maintain TMF standards, SOPs and controlled documents.
• Drive excellence through tools, processes, training and onboarding.
• Manage resources, hiring, mentoring and performance reviews.
• Support inspection readiness and CAPA/process improvements.
• Create metrics and KPI reports; identify risks, trends and opportunities.
• Serve as System Administrator for Veeva eTMF and evaluate improvements with IT.
• Support partner studies and assess TMF-related systems.
• Lead TMF vendor budget negotiations and spend.
• Interface with CTMS, EDMS, ISF and CDMS/EDC; guide TMF governance.

Skills

Leadership

Project Management

Communication

Negotiation

Attention to Detail

Regulatory Knowledge

Education

Bachelor’s degree (scientific preferred)

Tools

Veeva Vault

Veeva Applications

EDC/CTMS tools

Job description

Scorpion Therapeutics seeks an experienced TMF Operations Leader to oversee TMF program management, governance, and vendor oversight. You will drive standards, SOPs, and inspection readiness, ensuring compliant, scalable TMF processes across global studies.

Strong leadership and regulatory knowledge are essential. The role partners with IT to optimize Veeva eTMF and related systems, supports audits, and guides process improvements in a fast-paced environment.