Senior 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 forregionalstudy delivery withappropriate inspection readiness quality, within agreed timelines and budget 

• Leads theregional clinical operations team(including external partners working on a regional level)and acts aspoint of escalation for resolution of issues within the region for the assigned study

• Ensures alignment of regional deliverables with overall study goals  

Essential Functions of the job:  

Regional Leadership 

• Leads theregional clinical operations team effectively, ensures effective decision making and acts aspoint 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 andGlobal Clinical Study Manager asrequired 

• 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, andmaintains high quality study start up and recruitment timelines for region and tracks progress towards these 

• Ensures thatthe clinical study is operationallyfeasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medicalaffairs and any other stakeholders 

• Provides regional input on global study plans asrequired 

• Ensurestimely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensuretimely submission to regulatory authorities and ECs/IRBs 

• Accountable for submissions of study in countries in assignedregion 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 andQC’d on a regular basis as per the study TMF QC plan 

• Provides input to Global Clinical Suppliesregarding 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 withGlobal 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 withstudy 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 

• InformsGlobal Clinical Study Manager of any issues arisingon the study, evaluates impact and ensuressolutions are implemented 

• Preparessitesfor quality assurance auditsand inspections, drives responses to audit and inspection findings as appropriate 

• Collaborates withCST members andother colleagues to ensure cross-team, site learnings, and best practices are shared 

• Leads improvements and partners withCST members to enhanceefficiency and the quality of the work performed on assignedstudies 

• Contributes to development,optimization and review of work instructions and SOPs asrequired 

Budget and Resources 

• Works with the sourcing team to select and manage regional study vendors 

• Managesregional study budgets 

• Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities 

• Identifies and managesregional teamresource needs andestablishes contingency plans for key resources 

• Monitors regional resourceutilization over study lifecycle and liaises with functional managers as needed 

Supervisory Responsibilities:   

• Provides performance feedback on team members asrequired 

• Might mentors junior team members

Computer Skills:     

MS Office, Project Planning Applications 

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 

OtherQualifications:   

• 7 or more years of progressive experience in clinical research within biotech,pharma or CRO industry 

• Proven experience in clinical research including relevant experience as teamlead in clinical functions 

• Experience as CRA is preferred 

Travel:    

Travel might berequired as per business need 

Salary Range Romania: 335,000.00 RON - 418,800.00 RON

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.