Regional Clinical Study Manager

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. General Description: Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget  Leads the regional clinical operations team (including oversight of external partners working on the 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   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  Timelines, 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 reimbursement status of comparator drugs used in study for countries in region  Manages the trial data collection process for the region, drives data entry and query resolution  As required, supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing  Quality:  Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads  Monitors study activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations  Ensures inspection readiness for study in region at any point in time throughout the study life cycle  Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented  Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate  Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared  Leads improvements and partners with CST members to enhance efficiency and the quality of the work performed on assigned studies  Contributes to development, optimization and review of work instructions and SOPs as required  Budget and Resources  Works with the sourcing team to select and manage regional study vendors  Manages regional study budgets  Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities  Identifies and manages regional team resource needs and establishes contingency plans for key resources  Monitors regional resource utilization over study life cycle and liaises with functional managers as needed  Education Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred  *exceptions might be made for candidates with relevant clinical operations experience  Other Qualifications:     4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry  Proven experience in clinical research including relevant experience as team lead in clinical functions  Experience as CRA is preferred Supervisory Responsibilities:    Provides performance feedback on team members as required  Might mentor junior team members  Computer Skills:   Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook  Travel:  Travel might be required as per business need  Salary Range Germany: 83,400.00 EUR - 104,300.00 EUR Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.