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 forregional study delivery with appropriate inspection readiness quality, within agreed timelines and budget

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

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

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 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 other 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

Managesregional 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

Supervisory Responsibilities:

Provides performance feedback on team members as required

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

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

Travel:

Travel might be required as per business need

Salary Range: 281,600.00 PLN - 352,000.00 PLN

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.

Originally posted on Himalayas