About the role
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.
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
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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
Salary Range: $123,200.00 - $163,200.00 annuallyBeOne 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.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas