Senior Project Data Manager

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:

General Description:
The Senior Project Data Management’s role is responsible for all aspects of the clinical trial data management process from study start up through database lock and support of clinical study report (CSR) activities for assigned studies. This role is also accountable for quality of deliverables and resource efficiency of assigned studies. This role may be expected to lead multiple clinical studies and/or oversee multiple clinical studies.

This is an individual contributor role.

Essential Functions of the job:

• Lead studies and function as the Data Management primary point of contact for all study team members and vendor partners
• When leading studies, be able to influence CST with expertise to mitigate the risks of the studies.
• Oversee the technical performance of the data managers to ensure timelines are met and data timepoints are finalized at the highest data quality.
• Participate in Clinical Development taskforces and initiatives around standardization and technology, as needed
• Collaborate effectively with other program leads in data management to ensure consistency in data handling and management of teams
• Serve as an active member of Clinical Study Teams
• Work with other functions to manage timelines and ensure that clinical data management deadlines are met
• Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables
• Work with database builders to develop EDC databases, edit checks and reports
• May define database and edit check specifications to support the protocol and analyses
• May develop UAT requirements for new study databases and revisions
• Participate in database testing in accordance with UAT Plan
• Create and maintain data management documentation
• Regularly review and query clinical trial data as indicated in the Data Validation Specifications and Integrated Data Review Plan
• Help design listings in support of data management, clinical and medical reviews of data
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders
• May train other personnel on study-related items and data management principles, as needed
• Ensure coordination with Pharmacovigilance on adverse event reconciliation
• Working knowledge of SDTM and C-DASH principles and other industry guidelines preferred
• Collaborates with program lead and other functions to ensure program-consistent, high-quality and on-time data delivery
• Reviews and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
• May lead a product/program locally within Data Management as needed
• Support management team with continued process improvement/innovation for the department and participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
• Other duties as assigned

Qualification Required:

Education Required:
Bachelor’s degree or equivalent in a health-related field preferred

Computer Skills:
Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project) Working knowledge of more than three EDC systems, Medidata Rave required SAS Viewer and competencies in visualization tools.

Other Qualifications:

• 8+ years of experience in clinical data management in the pharmaceutical/biotechnology
• Have excellent experience working in cross-functional team-oriented environments
• Have strong oncology experience required
• Have strong project management skills, 5+ years of experience as Lead Data Manager
• Have experience developing Data Management standards
• Good understanding of ICH and regulatory environment as it pertains to data management
• During discussions with CST and other cross-functional teams, be capable of influencing others with decision making processes.
• Working knowledge of one or more EDC systems, Medidata Rave preferred
• Other duties as assigned
   

Travel:
Travel may be required as per business need, ability to travel domestically and internationally.

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.