обновлено 8 дней назад
Senior Trial Master File Manager (Clinical Trials)
10 944 000 - 14 592 000HUF
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Trial Master File Manager (Clinical Trials): Managing complex clinical trial documentation and eTMF activities for high-visibility studies with an accent on TMF completeness, inspection readiness, and regulated clinical development processes. Focus on leading audit preparation, supporting regulatory inspections, mentoring TMF managers, and driving AI-enabled process improvement and digital transformation.
Location: Budapest, Hungary; hybrid working
Salary: Ft10 944 000–Ft14 592 000 per year
Company
is a global healthcare company focused on developing medicines and improving patient outcomes.
What you will do
- Manage a portfolio of complex clinical trials and ensure Trial Master File completeness and quality.
- Lead inspection and audit preparation, including gap assessments, remediation coordination, and TMF guidance.
- Present and demonstrate the eTMF platform during inspections and respond to inspector questions.
- Guide and mentor TMF Managers, act as an escalation point, and support local assignment strategies.
- Lead or contribute to TMF process improvement, digital transformation, AI-enabled automation, and standards harmonization.
- Collaborate with contributor departments and represent in industry working groups.
Requirements
- BS/BA degree and 3 to 5+ years of experience managing TMFs or complex clinical documentation.
- Strong knowledge of TMF regulations, ICH-GCP guidelines, and clinical development processes.
- Experience leading or supervising teams in hierarchical or matrix environments.
- Project management experience in a complex, regulated environment, including metrics monitoring and analysis.
- Experience with Veeva eTMF, RIM, or a similar platform; good knowledge of Microsoft Office.
- Fluent written and verbal English communication skills.
Culture & Benefits
- Flexible home office policy in an award-winning workplace.
- Healthcare, prevention, wellness programs, and at least 14 weeks of gender-neutral parental leave.
- Structured onboarding and training with a dedicated Buddy.
- Supportive international work environment with community events, sports clubs, and wellbeing activities.
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