About us
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
Job Description:
Essential Functions of the job:
Management of people and resources
Is responsible for the hiring, training, development and retention of a team of CRAs to deliver quality monitoring to the Phase I-IV trials
Performs ongoing assessment and allocation of monitoring resources to ensure balanced workload for quality monitoring
Ensures CRAs have the required level of Monitoring area knowledge and skills to successfully deliver to protocol and study requirements
Is responsible for managing and addressing CRA performance and quality performance indicators, including managing timely site activation, recruitment commitments, timely data entry and issue resolution and appropriate application of established Monitoring procedures and tools in accordance with GCP, ICH, SOP's, and local regulations.
Adheres to and contributes to the development and review of Working Instructions and SOPs, if required
Allocation, initiation and conduct of trials
Allocate CRA resource (including FSP staff if applicable) in new and ongoing trials in collaboration with Clinical Monitoring teams.
Ensures trial site selection, activation, enrolment, data flow and timeline commitments are delivered per established Monitoring Key Performance Indicator trial objectives.
In collaboration with CSMs/PMs, reviews the status of planned versus actual site start-up, patient recruitment and supports implementation of strategies to correct deviations from proposed plan
Enhance BeiGene relationship with clinical sites, to ensure site performance to trial commitments and delivery of quality monitoring
Delivery of quality data and compliance to quality standards
Is accountable for monitoring quality and issue resolution through support of study monitoring visit report review to ensure quality trial oversight and appropriate issue escalation/resolution
Ensures CRA competency gaps are identified and resolved through targeted training curricula in collaboration with local trainer
Is responsible for execution of assessment visits (where required) to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies
Performs accompanied visits, if required
Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Supports site audits and inspection and ensures CAPA follow-up and implementation for monitor and site identified issues
Manages CRA adherence/compliance to SOPs and required training curricula
Qualification Required:
Education Required:
Bachelor of Science, with advanced degrees preferred, in science, business, engineering, and at least 5 years' experience in biotech, pharmaceuticals or a related field in the biotech/pharmaceutical industry.
Experiences Required:
This role is primarily a line/functional management role for clinical operations staff (only functional management for FSP staff) whereby preferred experience should include:
Bachelors degree or higher in a scientific or healthcare discipline preferred
1 year or above of people management in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
Solid understanding of career development and performance management activities
Evidence of team leadership and engagement capabilities
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
Therapeutic or medical knowledge preferred
Understanding of all aspects of monitoring and trial execution
Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (CNDA), local/National Health Authorities regulations and BeiGene standards
Computer Skills - Must be efficient in Microsoft Word, Excel, PowerPoint, and Outlook
Travel - As Needed
Other Qualifications:
Fluent in written and verbal English.
Full working rights in New Zealand
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant and performance-based annual equity plan!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.
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