Clinical Research Manager/Senior Clinical Research Manager (New Zealand)

at  BeiGene

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).
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.
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 appliable) 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 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

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.
Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (
https://www.beigene.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us

• 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 standard