Senior Clinical Data Manager
About us
BeOne 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 BeOne, please visit and follow us on LinkedIn and X (formerly known as Twitter).
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.
Job Description:
Purpose of Job
The Sr. Clinical Data Manager’s role is responsible for supporting 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 reports to the Manager, Data Management or higher.
Major Responsibilities
- Supports and works closely with study lead data manager(s) for assigned clinical studies.
- Performs data cleaning/reconciliation activities as specified in company procedural documents and study-specific Data Management (DM) documents.
- Manages queries on assigned clinical studies.
- Generates and delivers reports to study team members.
- Supports external data reconciliation, in addition to serious adverse event reconciliation.
- Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
- Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF Completion Guidelines).
- Helps to ensure DM documents are filed per company Standard Operating Procedures (SOP) and Work Instructions (WI).
- Supports eCRF and edit check specifications development as necessary to support data collection and analyses required by the protocol.
- May work closely with database builders during clinical database build and programming of eCRF, edit checks, and reports.
- Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
- Participates in UAT activities for data transfers and programmed report outputs.
- Assists with Site and User management in clinical database of assigned clinical studies.
- May lead one or more Phase I to Phase II studies under supervision of manager.
- May work with vendors such as central laboratories in support of timelines and data-related deliverables.
- May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
- May help train other personnel on eCRFs and EDC.
- May help support development and maintenance of SOP and WI related to data management activities.
- Other duties as assigned.
Qualification Required:
Qualification
- Bachelor’s degree or equivalent in a health-related field
- 3+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
- Oncology experience preferred
- Ability to work in cross-functional team-oriented environments
- Understanding for ICH and regulatory environment as it pertains to data management
- Experience with SDTM/CDASH
- Strong project management skills
- Excellent written, verbal and organizational skills
- Must be detail-oriented
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
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!
BeOne 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
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