обновлено 12 дней назад
Manager, TMF Systems and Operations (Biotech)
109 200 - 174 600$
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
Manager, TMF Systems and Operations (Biotech): Supporting CTMS and eTMF operations for clinical studies with an accent on data quality, document management, compliance, and inspection readiness. Focus on maintaining Veeva Vault systems, reconciling clinical data and documents, resolving CRO and vendor issues, and preparing for audits and inspections.
Location: Cambridge, Massachusetts, United States. Only U.S. persons are eligible due to U.S. export control requirements; non-U.S. persons cannot be sponsored for an export control license.
Salary: $109,200–$174,600 per year, with potential eligibility for a discretionary annual bonus, incentive compensation, or equity award.
Company
develops mRNA technology and medicines through clinical research, scientific innovation, and regulated biopharmaceutical operations.
What you will do
- Execute daily CTMS operations, including study, country, and site setup, user provisioning, workflow management, reporting, releases, and UAT.
- Set up and maintain TMF records throughout the clinical study lifecycle in the eTMF.
- Conduct TMF health checks, reconciliations, quality reviews, and inspection-readiness activities.
- Serve as TMF Lead on clinical trial teams and provide guidance and training on filing expectations and metadata accuracy.
- Partner with Clinical Operations, Data Management, Regulatory, QA, IT, CROs, and vendors to resolve data, document, and system issues.
- Improve processes, SOPs, work instructions, templates, and end-user onboarding for CTMS and eTMF operations.
Requirements
- Bachelor’s degree or equivalent work experience.
- At least 6 years of experience in clinical research or a related field, including at least 3 years of hands-on TMF and/or CTMS operations experience.
- Familiarity with ICH GCP and global clinical documentation requirements.
- Strong attention to detail, organizational skills, communication skills, and ability to manage multiple priorities cross-functionally.
- Must qualify as a U.S. person—a U.S. citizen, permanent resident, asylee, or refugee—to access export-controlled information.
- Non-U.S. persons cannot be sponsored for an export control license for this role.
Nice to have
- Working knowledge of Veeva Vault Clinical Suite, including CTMS and eTMF.
- Experience supporting audits or inspections.
Culture & Benefits
- Competitive healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs plus location-specific perks.
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