обновлено 7 дней назад
Site Contracts Lead
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
Site Contracts Lead (Clinical Research): Overseeing site contract negotiations, budgets, templates, and regulatory submission deliverables for clinical studies with an accent on legally binding agreements, country-level requirements, and sponsor communication. Focus on identifying contractual risks, resolving negotiation issues, coordinating study timelines, and guiding site contract negotiators to completion.
Location: United States of America
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics through clinical research services.
What you will do
- Oversee site contract negotiations with country experts for assigned clinical studies.
- Review contract language and budget changes requested by investigator sites and coordinate solutions with sponsors and country experts.
- Select and tailor study templates, including CTAs, NDAs, investigator grants, and related authorization documents.
- Coordinate final country- and site-level contracts and budgets with Regulatory Submission Managers.
- Identify contractual and budget risks, escalate legal issues, and recommend mitigation strategies.
- Manage contracting timelines, milestones, deliverables, and deadlines while guiding site contract negotiators.
Requirements
- Undergraduate degree or international equivalent in legal studies or life sciences; a law degree is preferred.
- At least 2 years of experience with global contract language, budget development, and negotiations, preferably in clinical studies.
- At least 1 year of CRO experience.
- Knowledge of contracts, non-disclosure agreements, powers of attorney, privacy laws, and cross-border data transfers.
- Working knowledge of ICH/GCP, FDA guidance, EU and local regulations, ISO 14155, drug and device development, and clinical monitoring procedures.
- Strong communication, negotiation, organization, time management, collaboration, and customer service skills.
Culture & Benefits
- Flexible working practices designed to support professional growth and work-life balance.
- Collaborative environment where employees can influence ways of working.
- Equal opportunity employment compliant with applicable federal guidelines.
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