Senior Clinical Data Manager — Remote Data Strategy Lead

Lifelancer Ltd; United States; Remote; USD 93.000 - 121.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision, & Life ins.

401(k) program with company match

Tuition reimbursement

Zusammenfassung

Biogen is seeking a Senior Clinical Data Manager, Remote (USA). You will support data management across the study lifecycle, working with cross-functional teams and leading data quality initiatives.

The role emphasizes adherence to regulatory guidelines and Biogen processes, with opportunities for process improvement and vendor collaboration. You will act as a subject matter expert, ensuring data integrity, coordinating with the Clinical Data Lead, and contributing to ongoing data strategy and

Qualifikationen

• Bachelor’s degree strongly preferred in a scientific discipline.
• 4+ years of Clinical Data Management experience required.
• Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and data review tools.
• Project management skills to collaborate with cross-functional functions.
• Excellent written and oral communication skills in English.

Aufgaben

• Design and test CRFs, edit checks, reports and listings; data cleaning; query management; risk identification and mitigation.
• Back up the Clinical Data Lead; provide SME support to cross-functional teams.
• Apply data strategy; ensure global standards; monitor study progress and reporting.
• Review study data for accuracy following Biogen processes and regulatory guidelines.
• Oversee reconciliation of EDC data with safety databases and external vendor systems.
• Investigate issues and propose solutions using experience and precedent.
• Communicate data topics across teams and escalate issues for timely resolution.
• Contribute to DM process development and innovation; assess vendor quality.

Kenntnisse

Clinical data management

Cross-functional collaboration

Project management

English communication

Ausbildung

Bachelor's degree

Tools

Medidata Rave

Data review tools

Elluminate

Jobbeschreibung

Biogen is seeking a Senior Clinical Data Manager, Remote (USA). You will support data management across the study lifecycle, working with cross-functional teams and leading data quality initiatives.

The role emphasizes adherence to regulatory guidelines and Biogen processes, with opportunities for process improvement and vendor collaboration. You will act as a subject matter expert, ensuring data integrity, coordinating with the Clinical Data Lead, and contributing to ongoing data strategy and