16 часов назад
Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology)
246 000 - 349 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology) (Clinical Compliance): Ensuring compliant clinical research execution across risk management, issue management, vendor oversight, site and data monitoring, and inspection readiness with an accent on ICH GCP, CAPA oversight, and cross-functional process standardization. Focus on designing risk and issue management frameworks, analyzing compliance trends, improving study execution, and coordinating with Quality Assurance and external suppliers.
Location: Remote within U.S. geographic markets; occasional travel to current or prospective vendor facilities may be required, at less than 10%.
Base salary: $246,000–$349,500 annually, adjusted according to geographic market, qualifications, experience, and internal equity.
Company
is a biotechnology company developing therapies and conducting clinical research in oncology.
What you will do
- Lead Clinical Operations risk and issue management to support compliant study execution.
- Define the functional risk and issue management strategy, methodology, and annual plan.
- Review monitoring outcomes, identify trends, and translate data into process improvements and risk-based decisions.
- Support CAPA owners through assignment, follow-up, completion tracking, and leadership reporting.
- Partner with Quality Assurance, Clinical Development, Data Management, R&D, and other functional teams.
- Standardize cross-study processes, templates, systems usage, and inspection-readiness activities.
Requirements
- Bachelor’s degree with at least 15 years of related experience, master’s degree with at least 13 years, doctoral degree with at least 12 years, or an equivalent combination.
- Biotechnology or pharmaceutical industry experience is required, including experience with CROs, R&D outsourcing, purchasing, or procurement.
- Senior-level team leadership and prior experience managing teams, consultants, or external suppliers.
- In-depth knowledge of biopharmaceutical regulations, standards, best practices, and the relevant scientific, legal, and regulatory environment.
- Strong leadership, communication, collaboration, analytical, strategic-thinking, problem-solving, change-management, and organizational skills.
- Advanced knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.
Culture & Benefits
- Remote work with equipment including dual monitors and ergonomic chairs.
- Medical, dental, vision, life, disability, and flexible spending account benefits.
- 401(k) plan with company contributions and access to company stock and long-term incentives.
- Discretionary annual bonus program.
- Fifteen accrued vacation days in the first year, 17 paid holidays, a company-wide winter shutdown, and up to 10 sick days annually.
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