[Hiring] Senior CRA Functional Manager @BeiGene

Role Description

The Sr. CRA Manager provides resourcing strategy and personnel oversight within the Site Management organization.

• Develops metrics and KPIs for CRA staff addressing new technology and analytic platforms monitoring for continuous improvement with output and results.
• Provides leadership for the CRA Managers and their staff ensuring accountability for study assignments, training, and metrics review.
• Provides performance management, coaching, and mentoring for their assigned management staff.
• Ensures proper monitoring expectations in collaboration with CTOMs, including adherence to monitoring SOPs, GCP guidelines, country-specific regulations, and general quality and risk-based effectiveness.
• 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.

Qualifications

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

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 turnaround 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 ensures engagement of direct reports.
• May conduct, attend, or support co-monitoring visits, as needed or 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.
• Assists in review of Monitoring reports with regard to quality oversight as needed.
• Provides support for site audits/inspections, as needed, and follows through with audit/inspection findings to resolution as it relates to involved CRA staff.

Benefits

• Salary Range: $136,400.00 - $181,400.00 annually.
• Eligible for annual bonus plan (Non-Commercial roles) or incentive compensation plan (Commercial roles).
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan.
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.