TMF Specialist Consultant

4 settimane fa

Italia Alira Health Group A tempo pieno

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

To manage and review the study documents of clinical trials

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

To manage and review the study documents of clinical trials

Job Description

Main Responsibilities

• Study documentation and Trial Master File (TMF/eTMF)

- Responsible for eTMF/paper TMF (in particular sections 10 and 11 of DIA Ref.Model) management of assigned studies, including the check of the completeness of the TMF, the quality of the documentation and the correctness of the TMF location.

- Responsible for eTMF and paper TMF reconciliation after study completion

- Be involved in TMF inspections.

- Collaborates with the project team with corrective and preventive actions, in case of deviations and audits.

Requirements

Proven experience in TMF Management;

Knowledge of Statistical and Data Management Processes

English fluency

Languages

Education

Contract Type

Contingency Workforce

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

Introduce yourself to our Recruiters Apply to one of our open jobs or send us your spontaneous application.

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