OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision. Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve. Job Description: The Manager, Clinical Research Quality will report to the VP, Clinical Research. This individual will collaborate with the VP, OneR operations team, and OneOncology practices to develop a quality department to support clinical research across the OneOncology network. The Manager, Clinical Research Quality is a key OneR role responsible for overseeing and ensuring the highest standards of quality and compliance within clinical research operations. This position requires a comprehensive understanding of regulatory requirements, industry standards, and best practices related to clinical research. This position plays a pivotal role in safeguarding the integrity, safety, and ethical conduct of clinical trials conducted within the organization, while also focusing on training and development initiatives to enhance the competency and capabilities of clinical research staff. Responsibilities Develop, implement, and maintain quality management systems to ensure compliance with regulatory requirements, industry standards, and internal policies. Establish and monitor key performance indicators (KPIs) to assess the effectiveness of quality management systems and drive continuous improvement initiatives. Conduct regular audits, inspections, and assessments to evaluate compliance with protocols, regulations, and standard operating procedures (SOPs). Interpret regulatory requirements and provide guidance to stakeholders on compliance issues, ensuring adherence to applicable laws and regulations. Collaborate with regulatory affairs and legal teams to address regulatory inquiries, submissions, and audits. Develop and deliver training programs on quality assurance, regulatory compliance, and best practices in clinical research. Assess training needs and develop curricula tailored to different roles and levels within the clinical research organization. Provide guidance and support to staff members involved in clinical research activities, fostering a culture of compliance, integrity, and continuous learning. Identify potential risks and vulnerabilities in clinical research processes, systems, and procedures. Develop risk mitigation strategies and process improvement plans to address identified risks and enhance the overall quality and compliance of clinical research operations. Collaborate closely with cross-functional teams and site research staff to ensure alignment and integration of quality processes. Maintain documentation of quality assurance activities, audit findings, corrective actions, and preventive measures. Prepare and present regular reports to senior management on the status of quality management systems, compliance initiatives, and audit outcomes. Key Competencies Demonstrated problem-solving and analytical capabilities. Knowledge of FDA, EMA, ICH, and other global regulatory requirements applicable to clinical research. Proven track record of leading quality management initiatives, conducting audits and inspections, and driving process improvements. Strong communication, and interpersonal skills. Proven ability to think critically, achieve results and manage tasks while adhering to multiple deadlines both independently and as part of a team. High emotional intelligence in partnering with research staff and other subject matter experts. Demonstrated success in building a team. Ability to work cross-functionally to deliver on key initiatives. Qualifications 4-8 years of experience clinical research quality assurance, regulatory compliance, training and education. Bachelor’s degree required, Advanced degree in a relevant scientific discipline preferred. Experience working with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other clinical research technologies preferred. Ability to travel ~25% Bachelor’s degree required, Advanced degree in a relevant scientific discipline preferred. #LI-LK1 OneOncology is the national platform for independent community oncology practices working together to improve the lives of everyone living with cancer through a physician-led, data-driven and patient-centric model. OneOncology provides practices on the platform with capital, innovative technology and expertise enabling them to grow, provide multi-disciplinary services along the continuum of care, incorporate the latest scientific developments as they emerge in the market, and attract the best physicians and employees as the landscape of oncology rapidly changes. OneOncology is comprised of practices representing nearly 600 providers practicing at more than 175 sites of care across the United States.