eTMF Compliance Lead — Audit-Ready Documentation

CTI Clinical Trial and Consulting Services; Lisboa; On-site; EUR 38,000 - 54,000; Full time

Benefits offered by this job

Health benefits

Hybrid work from home opportunities

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services in Lisbon, Portugal seeks an experienced TMF specialist to oversee eTMF processes, ensure compliance, and coordinate with RASSU, CPAs/CPCs, CRAs, and CPMs. You will drive document quality, assist audits, and maintain TMF timelines across trials.

Requirements include a Bachelor’s degree in allied health and 2–4 years in pharmaceutical or CRO regulatory/document/TMF management. The role offers hybrid work and benefits.

Qualifications

• Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
• 2-4 years pharmaceutical or CRO Clinical Regulatory and/or document / TMF management experience

Responsibilities

• Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor trial progress and ensure compliance with processes
• Oversee receipt and processing of essential trial documentation including review of content, quality, and completeness
• Ensure eTMF compliance and continual inspection readiness
• Interact with RASSU, CPAs/CPCs, CRAs, CPMs, eTMF Management, and other CTI functions for document corrections or resolutions
• Participation in internal, Sponsor, and regulatory authority audits and assist in responding to observations
• Organize review and assessment of eTMF for correct naming, filing, and completion of essential documents
• Ensure eTMF timelines, milestones and maintenance requirements are met
• Collaborate with eTMF Manager to organize administrative support for critical timelines
• Provide trial teams with accurate periodic status reports and attend meetings
• Conduct/oversee QC of trial-related essential documents and reports
• Assist with maintenance and QC of document trackers and reports
• Educate trial teams regarding patterns or errors in trial document quality and filing
• Collaborate with Document Processing Management on system enhancements and reporting needs
• Perform document quality review, reconciliation, close-out, shipment, and archiving per GSOPs/SOPs
• Forward and/or ship essential documentation to Sponsor per CTI or Sponsor SOPs

Skills

eTMF oversight and guidance

Compliance management

Documentation quality review

Audit support

Regulatory liaison

Education

Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience

Job description

CTI Clinical Trial and Consulting Services in Lisbon, Portugal seeks an experienced TMF specialist to oversee eTMF processes, ensure compliance, and coordinate with RASSU, CPAs/CPCs, CRAs, and CPMs. You will drive document quality, assist audits, and maintain TMF timelines across trials.

Requirements include a Bachelor’s degree in allied health and 2–4 years in pharmaceutical or CRO regulatory/document/TMF management. The role offers hybrid work and benefits.