About us 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: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget Acts as regional lead for multiple studies across an indication or across a program as required Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study Ensures alignment of regional deliverables with overall study goals Contributes to the development of regional tools and leads the development of work instructions and SOPs as required Essential Functions of the job: Regional Leadership Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study Leads external vendors involved in study delivery on a regional level Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings Leads regional operations meetings with all regional study team members Displays therapeutic area knowledge and expertiseTimelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders Provides regional input on global study plans as required Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs Ensures regional and country information in study systems and tools is entered and up to date Collaborates closely with CRAs in the region to ensure proper study execution at the sites.
Reviews and signs-off monitoring reports Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region. Provides input on local regulatory approval and reimbursem