Note: The job is a remote job and is open to candidates in USA. BeOne is a pharmaceutical and biotechnology company focused on developing medicines and fighting cancer. The Manager, Data Management Program Lead, Hematology will lead clinical studies and programs from a data management perspective, oversee data quality and timelines, and support process development, compliance, and operational efficiency. The role also collaborates with clinical study teams, vendors, and cross-functional partners on data management deliverables and standards.
Responsibilities
- 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
- Collaborates effectively with other program leads in data management to ensure consistency in data handling and management of teams
- Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables
- If assigned to a study, work with database builders to develop EDC databases, edit checks and reports
- May regularly review and query clinical trial data as indicated in the Data Validation Specifications and Integrated Data Review Plan
- Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
- May lead a product/program locally within Data Management as needed
- Supports the Data Management standards and process improvement initiatives
- Supports the development and maintenance of process documents (e.g., Standard Operating Procedures, Work Instructions) pertaining to Data Management activities
- Develops and provides training to BeOne and FSP data management and cross functional team members on SOPs, process and standards as required
- May drive inspection readiness, quality compliance, and training initiatives pertaining to Data Management
- May lead and/or oversee multiple clinical studies and programs
- May function as the Data Management primary point of contact for all study team members and vendor partners
- May oversee day to day activities of data managers working on clinical studies within a program
- May serve as an active member of Clinical Study Teams
- May work with other functions to manage timelines and ensure that data management deadlines are met
- May create and maintain study specific data management documentation
- May identify and troubleshoot operational problems, issues, obstacles, and barriers for studies, programs, and initiatives
- Program Lead role, individual should ensure consistency within the DM practice, while working with other DMPLs
- Other duties as assigned
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
- 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
- Travel may be required as per business need, ability to travel domestically and internationally
- Working knowledge of one or more EDC systems, Medidata Rave preferred
- Bachelor's degree or equivalent in a health-related field preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- Commercial roles are eligible to participate in an incentive compensation plan
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
- Voluntarily participate in the Employee Stock Purchase Plan
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Remote work
Company Overview