BeOne Medicines USA, Inc. seeks Manager, EDC Administration in Cambridge, MA:
Job Duties: Act as Data Management administrator lead in US for BeiGene EDC clinical studies. Assist with supporting cross functional systems such as CTMS, IRT etc. as needed and help setup necessary integrations. Add users, sites and upload local lab ranges in various EDC Systems. Assist with subject administration as well as site numbering process. Support integration between EDC and MDM. Perform quality control of Admin tasks. Generate and maintain all required documentation in support of DM Admin activities. Assist with Creation of SOPs, WIs and Templates for EDC administration. Help test external data loads, custom reports, integrations, EDC builds; and Supervise audit activities and Manage work of EDC Admins.
Full-time telecommuting is an option. Minimum Requirements: Master's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or closely related field, and 5 years of experience in the job offered or in any occupation in related field; or a Bachelor's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or closely related field, and 7 years of experience in the job offered or in any occupation in related field.
Special Skill Requirements: (1) Experience with Clinical Systems (Medidata Rave, Oracle Inform, Oracle CTMS, Medidata CTMS); (2) Experience Administering Clinical Data Warehouse Solutions; (3) Experience Creating and Maintaining SOPs and Work Instructions; (4) Experience using ticketing systems (Jira and Service Now); (5) Experience working with Pharma/Biotech cross-functional teams (Clinical Operations, Safety, Biometrics); (6) Experience with the systems and regulatory aspects of clinical trials; (7) Experience with industry standards (CDISC, 21 CFR Part 11, ICH GCP). Any suitable combination of education, training and/or experience is acceptable.
Full-time telecommuting is an option. Disregard the below range, the selected candidate will earn a wage of $136,406 - $165,000 per annum.
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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: $125,500.00 - $165,500.00 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.
