Senior CRA Functional Manager

BeOne Medicines USA; United States; On-site; USD 136,000 - 181,000; Full time

Job summary

BeOne Medicines USA is seeking a Sr. CRA Manager to lead the resourcing strategy for CRA staff in the Americas and oversee CRA Managers, ensuring accountability for study assignments and KPIs. This role drives performance through coaching and data-driven oversight.

Responsibilities include monitoring quality, adherence to GCP, and collaboration with CTOMs and CST to meet study milestones, with oncology global trials experience preferred.

Qualifications

• Minimum 8-9 years of relevant Clinical Operations experience.
• 4-5 years of personnel and trial management experience.
• Minimum 4-5 years of monitoring experience. Oncology global trials preferred.

Responsibilities

• Oversee resourcing strategy within Americas region for CRA staff.
• Lead CRA Managers and staff, ensuring accountability for study assignments and metrics.
• Develop metrics and KPIs for CRA staff and monitor performance.
• Oversee monitoring quality, trip report turnaround, and data currency in TMF.
• Collaborate with CTOMs and CST to ensure timely delivery of study milestones.

Skills

Leadership

Monitoring experience

Trial management

Data analysis

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:

• 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 va