Manager, EDC Administration

BeiGene•Cambridge, MA

7d•$125,500 - $165,500•Remote

About The Position

BeOne Medicines USA, Inc. seeks a Manager, EDC Administration in Cambridge, MA. This role involves acting as the Data Management administrator lead in the US for BeiGene EDC clinical studies. The position supports cross-functional systems such as CTMS and IRT, and helps set up necessary integrations. Key responsibilities include user and site management, uploading local lab ranges, subject administration, and site numbering. The role also supports integration between EDC and MDM, performs quality control of administrative tasks, generates and maintains documentation for DM Admin activities, and assists with the creation of SOPs, WIs, and templates for EDC administration. Additionally, the Manager will help test external data loads, custom reports, integrations, and EDC builds, supervise audit activities, and manage the work of EDC Admins. Full-time telecommuting is an option.

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.
Experience with Clinical Systems (Medidata Rave, Oracle Inform, Oracle CTMS, Medidata CTMS)
Experience Administering Clinical Data Warehouse Solutions
Experience Creating and Maintaining SOPs and Work Instructions
Experience using ticketing systems (Jira and Service Now)
Experience working with Pharma/Biotech cross-functional teams (Clinical Operations, Safety, Biometrics)
Experience with the systems and regulatory aspects of clinical trials
Experience with industry standards (CDISC, 21 CFR Part 11, ICH GCP)
Any suitable combination of education, training and/or experience is acceptable.

Responsibilities

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.
Supervise audit activities and Manage work of EDC Admins.