BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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 AD. CRA Manager provides/supports resourcing strategy and personnel oversight within the Site Management organization
The AD. CRA Manager develops/supports metrics and KPIs for CRA staff addressing new technology and analytic platforms monitoring for continuous improvement with output and results.
The AD. CRA Manager provides/supports leadership for the CRA Managers and their staff ensuring accountability for study assignments, training, and metrics review.
The AD. CRA Manager provides performance management, coaching and mentoring for their assigned staff.
The AD. 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 AD. 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
May also provide leadership to managers and professional staff
May also be accountable for the performance and results of multiple related teams
Supports SR Director to develops departmental plans, including business, production and/or organizational priorities
Decisions are guided by resource availability and organizational objectives
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 across CRA Managers
- Responsible for developing/supporting 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
Supervisory Responsibilities:
- May include supervision of CRA Management staff
- Supervision of CRA staff
- May supervise other roles as required within Site Management organization
- Support Director/Sr. Director to oversees resourcing output managing Head count to need and addressing projected work
- Oversees/Supports metrics and KPI for CRA staff in the Americas
- Provides necessary training to CRA management staff and CRA staff
- Co-monitoring as necessary with CRAs to ensure oversight and address site-related concerns
- Assists with the identification of development opportunities for junior team members
Education Required:
BS/BA in a relevant scientific discipline and minimum of 10 years of relevant Clinical Operations experience; > 5 of those a combination of personnel and trial management experience, and minimum of 5 years of monitoring experience. Experience in oncology global trials preferred.
Computer Skills:
- Efficient in Microsoft Word, Excel, PowerPoint, Teams and Outlook
- Familiar with industry CTMS and data management systems
Other Qualifications:
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- > 5 years of management or oversight within pharmaceutical or CRO Industry
- 4-5 > 5 years of (CRA) monitoring experience in the pharmaceutical or CRO Industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
Travel: up to 15-25% time
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- 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
We are proud to be an equal opportunity employer and we value diversity. 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.
