4 дня назад
Innovative Medicine R&D, Lead Site Contract Manager, Site Engagement Group, Contract & Grants, Global Development (Clinical Trials)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Innovative Medicine R&D, Lead Site Contract Manager, Site Engagement Group, Contract & Grants, Global Development (Clinical Trials): Developing, negotiating, and finalizing clinical trial agreements and related budgets for company-sponsored and investigator-initiated studies with an accent on contract compliance, risk assessment, and global stakeholder coordination. Focus on leading CRO oversight, resolving complex contracting issues, managing amendments, and improving clinical trial contracting processes.
Location: Chiyoda, Tokyo, Japan
Company
Johnson & Johnson MedTech develops healthcare solutions and innovative medicines intended to prevent, treat, and cure complex diseases.
What you will do
- Prepare, negotiate, and finalize clinical trial agreements, budgets, and ancillary agreements for sponsored and investigator-initiated studies.
- Analyze contractual requirements, investigator fees, fair-market-value pricing, legal risks, and study-specific tracking requirements.
- Coordinate with Healthcare Compliance, Risk Management, Privacy, clinical teams, and other stakeholders to resolve contractual and budget issues.
- Provide project management oversight, training, and supervision for CROs negotiating clinical trial agreements globally.
- Manage contract amendments, approvals, payments, and investigator grant compliance throughout the contract lifecycle.
- Onboard and mentor staff, improve contracting processes, and drive accountability, communication, and delivery against cycle-time targets.
Requirements
- Bachelor’s degree in a relevant scientific or business discipline.
- 3–5 years of experience or equivalent competencies in the pharmaceutical industry or clinical research, including at least 2 years of contract negotiation experience.
- Working knowledge of clinical development, clinical research processes, clinical trial management systems, and relevant compliance guidance including HIPAA, FCPA, and Safe Harbor.
- Strong negotiation, problem-solving, communication, organization, and cross-functional collaboration skills.
- Ability to work independently, manage substantial responsibilities with minimal supervision, and use Microsoft Office and database management tools.
- Fluency in English is required.
Nice to have
- Previous experience working in virtual teams.
- Experience training or mentoring team members and leading process improvements.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and merit.
- Cross-functional collaboration with global internal and external stakeholders.
- Approximately 10% travel.
- Work guided by clinical research ethics, standard operating procedures, quality assurance, and regulatory compliance requirements.
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