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.
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.
