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 region/country study delivery (depending on the assignment) with appropriate inspection readiness quality, within agreed timelines and budget  Leads the regional/country clinical operations team (including oversight of external partners working on the regional/country level) and acts as point of escalation for resolution of issues within the region for the assigned study  Ensures alignment of regional/country deliverables with overall study goals     Essential Functions of the job:     Regional/country Leadership  Leads the regional/country clinical operations team effectively, ensures effective decision making and acts as a point of escalation for the resolution of issues within the region/country for the assigned study   Leads external vendors involved in study delivery on a regional/country level  Collaborates with key stakeholders in the region/country and provides regular updates on study progress in the region/country to senior management and Global/Region-focused Clinical Study Manager as required  Represents the regional/country study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings  Leads regional/country operations meetings with all regional/country study team members    Timelines, Planning and Execution  Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region/country, in line with global/regional study timelines  Generates, manages, and maintains high-quality study start-up and recruitment timelines for the region/country and tracks progress towards these  Ensures that the clinical study is operationally feasible in the region/country, drives trial feasibility, country allocation and site selection process for the assigned region/country in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders  Provides regional/country input on global/regional study plans as required  Ensures timely availability of local adaptations of global/regional study documents, such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBs  Accountable for submissions of study in assigned region/countries in close collaboration with regional/country study start up team and regulatory affairs  Ensures regional/country information in study systems and tools is entered and up to date  Collaborates closely with CRAs in the region/country to ensure proper study execution at the sites. Reviews and signs off on monitoring reports  Responsible for working with regional/country teams to ensure that country and site level Trial Master File is created, maintained and QC’d regularly as per the study TMF QC plan  Provides input to Global Clinical Supplies regarding drug inventories in the region/country and reviews local drug labels for the region/country. Provides input on local regulatory approval and reimbursement status of comparator drugs used in the study for the assigned region/country  Manages the trial data collection process for the region/country, drives data entry and query resolution  As required, supports planning and execution of the Clinical Study Report in collaboration with Global/Region focused Clinical Study Manager and Medical Writing    Quality:  Handles escalated issues or problems with the sites in region/country 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/country at any point in time throughout the study life cycle  Informs Global/Region focused 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 the 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/country study vendors  Manages regional/country study budgets  Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities  Identifies and manages regional/country team resource needs and establishes contingency plans for key resources  Monitors regional/country resource utilization over study life cycle and liaises with functional managers as needed    Supervisory Responsibilities:    Provides performance feedback on team members as required  Might mentor junior team members ​  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  Computer Skills:    MS Office, Project Planning Applications    Other Qualifications:    At least 7 years of progressive experience in clinical research within biotech, pharma or CRO industry included 2 years of clinical study management/team lead experience  Experience as CRA is preferred    Travel:     Travel might be required as per business need    Salary Range Denmark: 736,000.00 DKK - 920,000.00 DKK Salary Range Netherlands: 70,900.00 EUR - 88,600.00 EUR Salary Range Belgium: 83,200.00 EUR - 104,000.00 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.