Global TMF Team Lead - Remote & Compliance

Jobgether SRL; Portugal; Remote; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Remote work flexibility

Global collaboration

Career development opportunities

Job summary

Jobgether is seeking a TMF Team Lead based in Portugal to oversee Trial Master File operations across multiple clinical studies. You will ensure inspection readiness, regulatory compliance, and high-quality document management in a global research environment.

Lead a cross-functional team, apply ALCOA principles, monitor KPIs, and collaborate with sponsors and QA stakeholders, while enabling remote work flexibility.

Qualifications

• Experience in clinical research operations.
• Strong knowledge of regulatory requirements (ICH GCP).
• Ability to lead teams in a highly regulated environment.
• Degree in Life Sciences or related field.
• 3–5 years of relevant experience.
• Experience supporting regulatory inspections (FDA/EMA/PMDA, etc.).
• Hands-on with document management systems and eTMF solutions.
• Experience in regulated industries, preferably clinical research.

Responsibilities

• Oversee TMF operations across multiple studies and ensure compliance.
• Maintain inspection readiness and ALCOA-compliant documentation.
• Monitor and improve TMF data quality and KPIs.
• Provide guidance on TMF processes to project teams and stakeholders.
• Mentor and develop TMF staff while promoting collaboration.
• Collaborate with sponsors, QA, and internal teams on quality assurance.

Skills

GCP knowledge

Leadership experience

Analytical skills

Regulatory experience

Communications

Education

Life Sciences degree or related field

Tools

eTMF systems (Veeva/Trial Interactive/Documentum)

Job description

Jobgether is seeking a TMF Team Lead based in Portugal to oversee Trial Master File operations across multiple clinical studies. You will ensure inspection readiness, regulatory compliance, and high-quality document management in a global research environment.

Lead a cross-functional team, apply ALCOA principles, monitor KPIs, and collaborate with sponsors and QA stakeholders, while enabling remote work flexibility.