[Hiring] Regional Clinical Study Associate Manager @BeiGene

Role Description

Accountable for regional study delivery or specific aspects hereof with appropriate inspection readiness quality, within agreed timelines and budget.

• Manages the regional clinical operations team (incl oversight of external partners working on the regional level).
• Acts as point of escalation for resolution of issues within the region for the assigned study.
• Supports the Regional Clinical Study (Sr) Manager with specific aspects of regional study delivery.
• Ensures alignment of regional deliverables with overall study goals.

Essential Functions of the Job

Regional Leadership

• Manages the regional clinical operations team effectively.
• Ensures effective decision making and acts as point of escalation for resolution of issues.
• Leads external vendors involved in study delivery on a regional level.
• Collaborates with key stakeholders in the region.
• Provides regular updates on study progress to senior management and Global Clinical Study Manager.
• Represents the regional study team at internal meetings and cross-functional Clinical Study Team (CST) meetings.
• May lead regional operations meetings with all regional study team members.

Timelines, Planning and Execution

• Manages planning and management of assigned clinical study(ies) from feasibility through closeout activities.
• Generates, manages, and maintains high quality study start up and recruitment timelines.
• Ensures operational feasibility in the region.
• Manages trial feasibility, country allocation, and site selection process.
• Provides regional input on global study plans.
• Ensures timely availability of local adaptations of global study documents.
• Accountable for submissions of study in countries in assigned region.
• Ensures regional and country information in study systems is up to date.
• Collaborates closely with CRAs in the region to ensure proper study execution.
• Responsible for maintaining the Trial Master File as per the study TMF QC Plan.
• Provides input to Global Clinical Supplies regarding drug inventories.
• Manages the trial data collection process for the region.
• Supports planning and execution of the Clinical Study Report.

Quality

• Handles escalated issues or problems with the sites in region.
• Monitors study activities to ensure compliance with study protocol, SOPs, ICH/GCP, and all other relevant regulations.
• Ensures inspection readiness for study in region.
• Informs Global Clinical Study Manager of any issues arising on the study.
• Prepares sites for quality assurance audits and inspections.
• Collaborates with CST members to ensure cross-team learnings and best practices are shared.
• Leads improvements and partners with CST members to enhance efficiency and quality.

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 and site payment issues.
• Identifies and manages regional team resource needs.
• Monitors regional resource utilization over study life cycle.

Qualifications

• Bachelor’s Degree in a scientific or healthcare discipline required.
• Higher Degree preferred.
• Exceptions might be made for candidates with relevant clinical operations experience.

Global Competencies

• 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

Salary Range

$96,300.00 - $131,300.00 annually. Actual compensation packages are determined by several factors unique to each candidate.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

BeOne is committed to fair and equitable compensation practices and 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.