Job Highlights
Not Disclosed
Posted 1 year ago
Job details
BeiGene 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
Qualifications
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
General Description
- The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
- May be assigned to CRA activities or start-up activities, depending on experience and project needs
- Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
- Identify gaps and areas for improvement and propose CAPA.
- Supports start-up and provides local expertise.
- The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
- Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets
- Provides protocol and related study training to assigned sites.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout) visit per monitoring plan and applicable SOPs
- Conducts co-monitoring visits, if required
- Completes monitoring visit reports in accordance with ICH-GCP, BeiGene standards and SOP
- Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends disease indication project specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
Qualifications
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- Ideally 2-4 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 and [French] (writing and speaking)
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- France
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 18, 2024
Company Overview
BeiGene
Current Openings: 0
BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more accessible and affordable to cancer patients worldwide. We have a commercial presence in more than 60 markets, with products treating various forms of cancer, and our broad and deep pipeline has the potential to address 80 percent of cancers by incidence. We have grown rapidly since our founding in 2010 to more than 9,000 colleagues working on five continents, including more than 950 oncology researchers, one of the largest such teams in the industry. We have administrative offices in Basel, Beijing and Cambridge, U.S. As we have grown, we have also evolved. In 2022, the company published its first Environmental, Social and Governance report and introduced “Change in the Cure,” a framework that provides a path for helping us shape a better world by advancing global health, improving access to medicines and ensuring quality in all our work. We have also introduced initiatives to improve work/life balance for our colleagues. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal. See our community guidelines: bit.ly/39o3O6j
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