Senior Clinical Research Manager

BeiGene Ltd.; United States; Remote; USD 136,000 - 181,000; Full time

Benefits offered by this job

Equity awards

Employee Stock Purchase Plan

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness program

Job summary

BeOne Medicines Ltd. seeks a Sr. CRA Manager to lead the Americas CRA staff, develop KPIs, and ensure quality monitoring and regulatory compliance. You will supervise CRA Managers, coach staff, and coordinate with CTOMs and CST to meet study milestones.

You will drive efficient resource allocation, oversee monitoring activities, and support audits, inspections, and investigator engagements across global oncology programs. Strong leadership and GCP knowledge are essential.

Qualifications

• BS/BA in a relevant scientific discipline; 8–9 years in Clinical Operations; 4–5 years in personnel and trial management; 4–5 years monitoring experience; oncology trials preferred.

Responsibilities

• Efficient resourcing strategy within Americas region for CRA staff.
• Lead CRA Managers and oversee staff performance.
• Develop and monitor metrics and KPIs for CRA team.
• Oversee monitoring quality, email/triage items, data currency, TMF management.
• Coordinate with CRO FSP line manager and address feedback on studies.
• Escalate CRA issues to CTOMs and ensure training allocations.
• Support site monitoring visits, investigator meetings, and risk assessments.
• Review monitoring reports for quality oversight; assist audits/inspections.

Skills

Resource planning

Leadership

KPIs & metrics

CRA oversight

Performance management

GCP compliance

Risk-based monitoring

Stakeholder communication

Education

BS/BA in a relevant scientific discipline

Job description

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:

• The Sr. CRA Manager provides resourcing strategy and personnel oversight within the Site Management organization
• The Sr. CRA Manager develops metrics and KPIs for CRA staff addressing new technology and analytic platforms monitoring for continuous improvement with output and results.
• The Sr. CRA Manager provides leadership for the CRA Managers and their staff ensuring accountability for study assignments, training, and metrics review.
• The Sr. CRA Manager provides performance management, coaching and mentoring for their assigned management staff.
• The Sr. CRA Manager ensures proper monitoring expectations in collaboration with CTOMs; including but not limited to adherence to monitoring SOPs, GCP guidelines, country-specific regulations, and general quality and risk-based effectiveness
• The Sr. CRA Manager may complete assessments visits for assigned staff as required and as contracted.
• Proactively seeks opportunities to lead and drive improvements to optimize effectiveness and efficiencies within the Site Management organization as well as within the greater Americas region

Essential Functions of the job:

The following functions may apply based on study and program requirements:

• Responsible for efficient resourcing strategy within Americas region for CRA staff
• Responsible for leading CRA Managers
• Responsible for developing metrics and KPIs for CRA staff
• Responsible for CRA oversight with regard to Functional Management related to projects direct reports are assigned to
• Responsible for performance management of BeiGene assigned staff
• Responsible for oversight of monitoring quality, metrics associated with monitoring including but not limited to: trip report turn around metrics, quality of trip report, action item management, query management, data currency and TMF management
• Responsible for managing relationship with CRO FSP line manager and liaising to understand and respond to feedback regarding individual direct reports or feedback about BeiGene studies or programs.
• Acts as the escalation point person for CTOM(s) and study teams with CRA related issues and concerns
• Works with CTOMs to ensure adequate monitoring allocations and relevant training are correctly assigned for direct reports’ projects.
• Supports BeiGene RBx strategy and ensure engagement of direct reports.
• May conduct, attend, or support co-monitoring visits, as needed or as necessary to evaluate CRA staff
• May attend, or support at Investigator meetings or Booster type visits to evaluate CRA staff
• Documents monitoring oversight activities appropriately following ICH-GCP and BeiGene standards
• Assists with investigator/site identification
• Working with CTOMs and Clinical Study Team (CST), manages site trends through dashboard review and ongoing risk assessment to ensure quality standards and address concerns associated with study delivery at sites.
• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Establishes regular lines of communication with CST, CTOMs and additional internal and external stakeholders to manage CRA clinical delivery and report/escalate any issues to the COM. Clinical Operations
• Assists in review of Monitoring reports with regard to quality oversight as needed
• Provide support for site audits/inspections, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff

Education Required:

BS/BA in a relevant scientific discipline and minimum of 8-9 years of relevant Clinical Operations experience; 4-5 of those a combination of personnel and trial management experience, and minimum of 4-5 years of monitoring experience. Experience in oncology global trials preferred.

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: $136,400.00 - $181,400.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail] .