Senior Clinical Research Associate

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 Senior CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs. Performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region.

The Senior CRA is responsible for performing quality oversight site visits and collaborating closely with the Clinical Operations Study Lead to ensure study timelines are adhered to and required quality standards are maintained, mentor and manage CRAs.

Essential Functions of the job:

The following functions may apply based on study and program requirements;

• Mentor and manage junior staff and Clinical Research Associates
• Acts as the escalation point person for CRA(s) with site related issues and concerns
• Review RFPs and SOWs to ensure adequate CRO monitoring and relevant CRO procedures are correctly reflected
• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs
• Conducts co-monitoring visits, if required
• Conducts Quality Oversight Visits (QOV) or other monitoring visits, as requested
• Completes monitoring visit/ QOV reports timely
• Documents monitoring activities appropriately following ICH-GCP and BeiGene standards
• Assists with investigator/site identification
• Provides protocol and related study training to assigned sites
• Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborates with Clinical Operations Study Lead and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Supports the Clinical Operations Study lead to manage the clinical study sites, as required
• Establish regular lines of communication with sites and reports site progress and issues to Clinical Operations
• Support with study plans, development of presentations to support milestones and related key findings
• Authors or reviews monitoring plan and recruitment plan
• Helps to develop and reviews site specific recruitment materials and tools
• Attends disease indication project specific training and general CRA training as required
• Facilitate site audits and/or inspections
• Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate
• Attends regional investigator meeting and site booster visits, as required
• Perform and support as needed the Clinical Study Lead with clinical data review of listings for completeness during key submission times

Supervisory Responsibilities:

• Provide mentoring and oversight of junior staff and Clinical Research Associates
• Provide necessary training to CRAs, support site visits as needed
• Develop training plan(s) for CRAs and related team members
• Co-monitoring with BeiGene CRAs if needed to ensure oversight and address site related concerns
• Assist with the identification of development opportunities for junior team members

Education Required:

• BS in a relevant scientific discipline and minimum of 5 year of relevant Clinical Operations experience and minimum of 3 years of monitoring experience.
• Experience in oncology global trials preferred

Computer Skills: Efficient in Microsoft Word, Excel, and Outlook

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• 3-5 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
• Fluent in English (writing and speaking) and Polish

Travel: up to 40-70% 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.