Manager, Regional Clinical Trial Management

About the role

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: General Description: BeOne is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. The Associate/ Manager/ Senior Manager, Regional Clinical Trial Management, is accountable to ensure that the teams deliver and meet work deliverables as per the agreed business expectations and timelines. Essential Functions of the job: Management of people and resources. Responsible for the hiring, training, development and retention of a team of rCTMAs to deliver quality administrative support to the Phase I-IV, HV trials. For FSP staff, evaluate CVs provided by the CRO and conduct "Meet&Greet" with the candidates. Conduct regular 1:1s with up to 12 direct reports (may be a group of BeOne internal rCTMAs and FSP rCTMAs) to assess workload, provide feedback, track goals, development. For the FSP rCTMAs, ensure timely feedback to CRO Line Manager. Performs ongoing assessment and allocation of resources within study team to ensure balanced workload for quality administrative support Ensures rCTMAs have the required level of administrative knowledge and skills to successfully deliver to protocol and study requirements Is responsible for managing and addressing rCTMA performance and quality performance indicators, procedures and tools in accordance with GCP, ICH, SOP's, and local regulations. Conduct year-end performance reviews in Workday and feedback in the moment throughout the year to timely address any gaps and provide support as needed. Adheres to and contributes to the development and review of Working Instructions and SOPs, if required Proactively provide and drive changes to the Clinical Operations processes. Allocation, initiation and conduct of trials Allocate rCTMA resource (including FSP staff if appliable) in new and ongoing trials in collaboration with Clinical Monitoring teams. Delivery of quality data and compliance to quality standards Ensures rCTMA competency gaps are identified and resolved through targeted training curricula in collaboration with local trainers. Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements Supports site audits and inspection and ensures CAPA follow-up Manages rCTMA adherence/compliance to SOPs and required training curricula Support other business activities such as initiatives, as required Qualification Required: Experience Required: This role is primarily a line/functional management role for clinical operations staff (only functional management for FSP staff) whereby preferred experience should include: Bachelor's degree or higher in a scientific or healthcare discipline preferred Solid understanding of career development and performance management activities Evidence of team leadership and engagement capabilities. Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required. Therapeutic or medical knowledge in oncology preferred. Understanding of all aspects of monitoring and trial execution Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues. Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (CNDA), local/National Health Authorities regulations and BeOne standards At least 4 years prior clinical trial experience including experience in a management/leadership capacity or demonstrating prior ownership of management/leadership type task At least

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