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.
PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION
Location: Sao Paulo Hybrid
Language Requirement: Portuguese and English Required and Spanish highly preferred
Required Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology
General Description:
The CRA Manager provides resourcing, oversight, study assignment, training, and metrics review for assigned CRAs, which are comprised of internal and external staff. The CRA Manager is also responsible for coaching and mentoring, and performance management for BeiGene staff. The 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 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 group as well as within the greater Americas region.
Essential Functions:
The following functions may apply based on study and program requirements:
- 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 and issues to 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.
Minimum Requirements – Education and Experience:
BS/BA in a relevant scientific discipline and minimum of 6 years of relevant Clinical Operations experience; 1 of those being management experience, and minimum of 4-5 years of monitoring experience. Experience in oncology global trials preferred.
Other Experience:
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- 2-3 years of management or oversight within pharmaceutical or CRO Industry
- 2-3 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
Supervisory Responsibilities:
Supervision of CRA staff:
- May supervise other roles as required within Site Management organization.
- Provides necessary training to CRA staff and support site visits, as needed.
- Co-monitoring as necessary with CRAs, if needed, to ensure oversight and address site-related concerns.
- Assists with the identification of development opportunities for junior team members.
Travel: up to 15-25% time
Computer Skills:
- Efficient in Microsoft Word, Excel, and Outlook
- Familiar with industry CTMS and data management systems
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. 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.
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