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.