Project 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 www.beonemedicines.com 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:

General Description: Project Data Management 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 CRO/FSP vendors for multiple clinical studies.

Essential Functions of the Job:

• Lead studies within a program
• Oversee data managers working on studies either in-house or CRO/FSP resources
• Serves as active member of Clinical Study Teams.
• Collaborates with other functions to develop timelines and ensure that clinical data management deadlines are met.
• Defines external data transfer specifications and works with external vendors in support of timelines and data related deliverables.
• Ensures process is in place to review and reconcile lab data with lab normal ranges
• Develops or oversees development of eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, edit checks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
• Develops or oversees development of study-specific eCRF Completion Guidelines and Data Management Plans
• Creates and maintains data management documentation.
• Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Works with coding group to ensure coding is applied to assigned clinical studies in conjunction with study timelines and deliverables.
• Defines listings in support of data management, clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
• Will have the opportunity to drive all data review related activities. This will also include identifying and escalating potential data issues to LDM when issues arise.
• Trains other personnel on eCRFs and EDC, as needed.
• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
• 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.
• Will oversees data managers working on studies either in-house or CRO/FSP resources to ensure studying the support on the studies are sufficient.
• Collaborates with program lead and other functions to ensure program-consistent, highquality and on-time data delivery.
• May mentor other junior Clinical Data Managers.
• Other duties as assigned.

Qualification Required:

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

Computer Skills:

• Proficient computer skills, including Microsoft Office applications
• Working knowledge of at least one EDC system, Medidata Rave is preferred

 

Other Qualifications:

• 6+ 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 of 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

 

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!)

• 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

BeOne 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 BeOne’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 BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.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) BeOne’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) BeOne’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.