Manager, EDC Administration

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $136.4k - $165k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥️ Administration

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Act as Data Management administrator lead in the US for EDC clinical studies • Support cross-functional systems such as CTMS and IRT and help set up integrations • Add users and sites and upload local lab ranges in EDC systems • Assist with subject administration and site numbering • Support integration between EDC and MDM • Perform quality control of administrative tasks • Generate and maintain documentation supporting DM Admin activities • Assist with creating SOPs, work instructions, and templates for EDC administration • Test external data loads, custom reports, integrations, and EDC builds • Supervise audit activities • Manage the work of EDC Administrators

🎯 Requirements

• Master's degree or foreign equivalent in Computer Science, Engineering, or closely related field, and 5 years of relevant experience; or Bachelor's degree or foreign equivalent in Computer Science, Engineering, or closely related field, and 7 years of relevant experience • Experience with clinical systems including Medidata Rave, Oracle Inform, Oracle CTMS, and Medidata CTMS • Experience administering clinical data warehouse solutions • Experience creating and maintaining SOPs and work instructions • Experience using Jira and ServiceNow ticketing systems • Experience working with Pharma/Biotech cross-functional teams including Clinical Operations, Safety, and Biometrics • Experience with clinical trial systems and regulatory aspects • Experience with industry standards including CDISC, 21 CFR Part 11, and ICH GCP • Any suitable combination of education, training, and/or experience is acceptable

🏖️ Benefits

• Full-time telecommuting option • Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness