Manager, EDC Administration

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Serve as the Data Management administrator lead in the United States for EDC clinical studies.

• Provide support for cross-functional systems such as CTMS and IRT, assisting in the establishment of integrations.

• Add users and sites, as well as upload local lab ranges within EDC systems.

• Assist with subject administration and site numbering tasks.

• Facilitate integration between EDC and MDM systems.

• Conduct quality control for administrative tasks.

• Create and maintain documentation that supports DM Admin activities.

• Aid in the development of SOPs, work instructions, and templates for EDC administration.

• Test external data loads, custom reports, integrations, and EDC builds.

• Oversee audit activities.

• Manage the responsibilities of EDC Administrators.

⛳️ Requirements

• A Master's degree or foreign equivalent in Computer Science, Engineering, or a closely related field, along with 5 years of relevant experience; or a Bachelor's degree or foreign equivalent in Computer Science, Engineering, or a closely related field, accompanied by 7 years of relevant experience.

• Proficiency with clinical systems including Medidata Rave, Oracle Inform, Oracle CTMS, and Medidata CTMS.

• Experience in administering clinical data warehouse solutions.

• Proven experience in creating and maintaining SOPs and work instructions.

• Familiarity with using Jira and ServiceNow ticketing systems.

• Background in working with Pharma/Biotech cross-functional teams, including Clinical Operations, Safety, and Biometrics.

• Knowledge of clinical trial systems and associated regulatory aspects.

• Understanding of industry standards such as CDISC, 21 CFR Part 11, and ICH GCP.

• Any appropriate combination of education, training, and/or experience is acceptable.

🏝️ Benefits

• Option for full-time telecommuting.

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account.

• Life Insurance.

• Paid Time Off.

• Wellness programs.