eTMF Spec I

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

• Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues identified and take corrective action where necessary
• Oversee receipt and processing of essential trial documentation including review of content, quality, and completeness
• Ensure eTMF compliance and continual inspection readiness
• Interact with Regulatory Affairs Study Start-up (RASSU), Clinical Project Assistants / Clinical Project Coordinators (CPAs / CPCs), Clinical Research Associates (CRAs), Clinical Project Managers (CPMs), eTMF Management, and other CTI functions for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during content quality review
• Participation in internal, Sponsor, and regulatory authority audits and assist in responding to observations
• Organize review / regular assessment of eTMF regarding correct naming, filing, as well as completion of essential documents
• Ensure eTMF compliance with the achievement of established TMF timelines, milestones and appropriate trial maintenance requirements at all stages of trial conduct are met
• Collaborate with eTMF Manager to organize administrative support in case of critical timelines on specific projects
• Provide trial teams and/or Sponsor with accurate periodic status reports in accordance with CTI GSOPs and attend internal and external trial meetings as needed
• Conduct / oversee QC of various trial-related essential documents and reports
• Assist with maintenance and QC of various trial-related essential document trackers and reports
• Access QC findings and document processing rejections, and educate trial teams and document processors regarding any identified patterns or errors in trial document quality and filing
• Collaborate with Document Processing Management and provide input into potential system enhancements, updates, and reporting needs
• Perform document quality review, reconciliation, close-out, shipment, and archiving activities of essential documentation according to CTI GSOPs and/or Sponsor SOPs
• Forward and/or ship essential documentation to Sponsor in accordance with CTI or Sponsor SOPs

What You'll Do

• Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues identified and take corrective action where necessary
• Oversee receipt and processing of essential trial documentation including review of content, quality, and completeness
• Ensure eTMF compliance and continual inspection readiness
• Interact with Regulatory Affairs Study Start-up (RASSU), Clinical Project Assistants / Clinical Project Coordinators (CPAs / CPCs), Clinical Research Associates (CRAs), Clinical Project Managers (CPMs), eTMF Management, and other CTI functions for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during content quality review
• Participation in internal, Sponsor, and regulatory authority audits and assist in responding to observations
• Organize review / regular assessment of eTMF regarding correct naming, filing, as well as completion of essential documents
• Ensure eTMF compliance with the achievement of established TMF timelines, milestones and appropriate trial maintenance requirements at all stages of trial conduct are met
• Collaborate with eTMF Manager to organize administrative support in case of critical timelines on specific projects
• Provide trial teams and/or Sponsor with accurate periodic status reports in accordance with CTI GSOPs and attend internal and external trial meetings as needed
• Conduct / oversee QC of various trial-related essential documents and reports
• Assist with maintenance and QC of various trial-related essential document trackers and reports
• Access QC findings and document processing rejections, and educate trial teams and document processors regarding any identified patterns or errors in trial document quality and filing
• Collaborate with Document Processing Management and provide input into potential system enhancements, updates, and reporting needs
• Perform document quality review, reconciliation, close-out, shipment, and archiving activities of essential documentation according to CTI GSOPs and/or Sponsor SOPs
• Forward and/or ship essential documentation to Sponsor in accordance with CTI or Sponsor SOPs

What You'll Bring

• 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

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.

Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.

Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.