OneOncology ยท 4 hours ago
Manager, Research Regulatory
United States
Full-time
Remote
Mid Level
4+ years exp
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Responsibilities
Leading and managing a team of regulatory affairs professionals, providing guidance, support and mentorship as needed.
Foster a collaborative and positive team environment, promoting open communication and teamwork.
Monitor performance and productivity of regulatory specialists, identifying areas for improvement and implementing process enhancements to optimize regulatory operations.
Developing and implementing regulatory strategies for clinical research and ensuring compliance with applicable regulations and guidelines.
Keeping abreast of changes in regulations and guidelines related to clinical research and implementing changes in the regulatory process as necessary.
In collaboration with Quality Assurance, ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements.
Review and modify study specific informed consent forms for readability, clarification of payments, costs, and standard of care language, and to ensure that all elements required by the Food and Drug Administration (FDA) are included.
Prepare, route, and submit essential regulatory documents to sponsors/CROs on behalf of network practices.
Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements.
Coordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirements.
Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards.
Establish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissions.
Track and communicate regulatory submission timelines, milestones, and status updates to internal stakeholders.
Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices.
Stay informed about changes in regulatory requirements and industry standards and disseminate relevant information to team members.
Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration.
Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.
Qualification
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Required
Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required
Minimum of 4-5 years of experience in clinical research, with a focus on regulatory affairs and compliance
Minimum of 1-2 years of supervisory experience
Expert understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards
Exceptional attention to detail and organizational skills
Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams
Ability to work independently and collaboratively in a fast-paced environment
Preferred
advanced degree preferred; extensive experience and proven track record may be considered in place of education requirements
Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems, electronic regulatory binder system, and clinical trial management systems (CTMS) preferred
Certification in clinical research (e.g., SoCRA, ACRP) is preferred
Company
OneOncology
OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Cencora
2023-04-20Secondary Market
2023-04-20Acquired
Leadership Team
Davey Daniel
Chief Medical Officer
Ian Flinn
Chief Scientific Officer
Recent News
2024-05-21
The Business Journals
2024-05-20
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