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.
Submit resume with references to: Req.#: L24-150312 at: ATTN: Amy Nobriga,
[email protected].
\#LI-DNI
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.