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 Clinical Research Regulatory Specialist will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The Clinical Research Regulatory Specialist will play a crucial role in ensuring compliance with regulatory requirements and guidelines for our clinical research projects. The Clinical Research Regulatory Specialist will work closely with cross-functional teams to facilitate the regulatory aspects of clinical trials, ensuring smooth and efficient processes from study initiation through to completion. Additionally, they will engage with various practices within our network to streamline regulatory processes and foster collaboration. Responsibilities - Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements. - Prepare, submit, and maintain regulatory documents, such as investigational new drug (IND) applications, amendments, and annual reports. - Coordinate regulatory submissions to regulatory authorities and ethics committees, ensuring timely and accurate completion. - Assist in the review of clinical trial protocols, informed consent forms, and other study-related documents to ensure compliance with regulatory standards. - 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. Key Competencies - Strong 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 Qualifications - Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required; advanced degree preferred - Minimum of 1-2 years of experience in clinical research, with a focus on regulatory affairs and compliance - 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 a plus. #LI-REMOTE

We’re looking for a meticulous, tech-curious Survey Fielding & Quality Specialist to help launch, monitor, and maintain the quality of online survey projects. You’ll be the behind-the-scenes expert ensuring every study runs smoothly — from setup through clean, balanced data delivery. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and takes pride in precision and process improvement. Responsibilities - Configure and launch online surveys, ensuring correct targeting, sampling, and logic before fielding begins - Monitor live survey progress to ensure balanced sampling, consistent completion rates, and reliable responses - Conduct quality assurance checks to identify irregularities such as incomplete responses, speeders, or demographic imbalances - Collaborate with research, data, or engineering teams to troubleshoot fielding or platform issues - Maintain detailed documentation of survey launches, checks, and resolutions - Support process improvements to enhance data accuracy and efficiency

We’re looking for a meticulous, tech-curious Survey Fielding & Quality Specialist to help launch, monitor, and maintain the quality of online survey projects. You’ll be the behind-the-scenes expert ensuring every study runs smoothly — from setup through clean, balanced data delivery. This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and takes pride in precision and process improvement. Responsibilities - Configure and launch online surveys, ensuring correct targeting, sampling, and logic before fielding begins - Monitor live survey progress to ensure balanced sampling, consistent completion rates, and reliable responses - Conduct quality assurance checks to identify irregularities such as incomplete responses, speeders, or demographic imbalances - Collaborate with research, data, or engineering teams to troubleshoot fielding or platform issues - Maintain detailed documentation of survey launches, checks, and resolutions - Support process improvements to enhance data accuracy and efficiency

Recall Analyst​ Lisbon, Portugal Remote/Home-based The Recall Analyst will play a critical role in managing and coordinating recall projects, ensuring that manufacturers effectively communicate product issues to their clients. This position involves handling inbound and outbound calls, maintaining project documentation, coordinating communications, and supporting recall management activities. The ideal candidate will be organized, detail-oriented, and capable of handling multiple tasks simultaneously. Call Handling: - Serve as the primary contact healthcare professionals participating in recall projects. - Handle inbound and outbound calls related to recall inquiries, providing accurate and timely information. - Facilitate completion of protocol-specific tasks remotely using the telephone, email, fax, and various portals. Documentation Management: - Maintain all recall project documentation files and records. - Ensure all project-specific information is accurately updated and maintained in internal databases, tracking systems, and project plans. - Monitor recall progress and ensure compliance with industry standards and regulations. Required Knowledge, Skills, and Abilities: Education & experience: - College certificate or equivalent experience (12 years of studies); - Previous experience in a BPO with technology support or clinical a plus; - Knowledge of Pharma industry is a plus; Mandatory skills: - English - Fluent - Mandatory - Italian - Fluent - Mandatory - Windows Operating System; - Microsoft Office; Working arrangement: - This position is Remote/Home-based in Portugal - Working hours: 11:00 to 20:00 and 13:00 to 22:00. Why Join? Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. You will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry. You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries. We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. It's an exciting time to join and reimagine what's possible in healthcare. IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential. IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.