General Description:

The Program Lead may be responsible for leading multiple clinical studies and/or multiple programs from the Data Management perspective. The role may also be responsible for process development and process improvement activities to ensure quality, compliance, consistency, as well as increase operational efficiency within Data Management.

This is an individual contributor role.

Essential Functions of the Job:

• 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

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.

Education Required:

Bachelor's degree or equivalent in a health-related field preferred

Salary Range: $141,700.00 - $186,700.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and 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 and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.