The Manager of Regulatory Operations provides leadership to a team ensuring compliant regulatory submissions and maintenance of investigator site files. They oversee day-to-day operations, monitor performance metrics, and collaborate with cross-functional stakeholders to improve systems and workflows.
The Senior Director will provide executive leadership and strategic oversight for pharmacy operations across the European network, ensuring compliance with regulatory standards. They will lead investigational drug services, drive operational excellence, and mentor pharmacy teams to support organizational growth.
The Regulatory Operations Specialist is responsible for preparing and submitting clinical study documents to the IRB, FDA, and IBC. They also maintain the Investigator Site File and serve as the primary point of contact for regulatory submissions and sponsor inquiries.
The Lead, Regulatory Operations serves as the subject-matter expert, providing guidance and operational oversight to the team while managing complex regulatory submissions to the FDA, IRB, and IBC. This role is responsible for ensuring compliance, mentoring staff, and driving process improvements to meet departmental goals.
The Director of Employee Health and Safety will provide strategic leadership for the EHS program across clinical operations, ensuring compliance with federal and state regulations. This role involves designing safety protocols, managing occupational health programs, and partnering with cross-functional teams to mitigate risk and foster a culture of safety.
The Director of Nursing provides proactive leadership and supervision to clinical staff, including nurses, navigators, and intake coordinators. They ensure high-quality patient care, regulatory compliance, and efficient operational workflows across all clinical research departments.
