Sr Clinical Data Manager, WCH

Overview

The Senior Clinical Data Manager is a support-level team member providing subject matter expertise in the operational aspects of Clinical Data Management for assigned clinical trials, sharing accountability with the Clinical Data Lead across the study lifecycle.

What you'll do

• Perform assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports and listings.
• Create documents, clean data, manage queries, and identify and mitigate risks.
• Act as back-up to the Clinical Data Lead, providing subject matter expertise and support to cross-functional teams.
• Apply data strategy, confirm use of global standards, support cross-functional study team members, and assist in monitoring and reporting overall study progress.
• Accountably review study data comprehensively, ensuring tasks follow Biogen processes, regulatory guidelines and study-specific plans.
• Perform or oversee reconciliation of EDC data with other sources, such as the safety database and external vendor systems.
• Investigate issues and recommend solutions using experience, judgement and precedent.
• Review study metrics and communicate data topics across internal and external teams, escalating relevant issues for timely resolution.
• Contribute to development of Data Management processes, including new process creation, process improvement and innovation.
• Support assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers.
• Participate in cross-functional collaborations, including study-level activities and special projects or initiatives.

What you'll need

• 4+ years of Clinical Data Management experience.
• Robust technical experience with Electronic Data Capture platforms.
• Project management skills to collaborate effectively with various business functions.
• Excellent written and oral communication skills in English.
• Ability to communicate effectively with a variety of cross-functional teams in a variety of scenarios.
• High attention to detail, with proven ability to manage multiple competing priorities successfully.
• Understanding of drug development and the biopharmaceutical industry.
• Bachelor's degree in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology or Social Science.

Nice to have

• Bachelor's degree strongly preferred in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology or Social Science.
• Experience with Medidata Rave for Electronic Data Capture.
• Experience with Elluminate for data review.

Details

• Job level: Professional.
• Base compensation range: $93,000.00-$120,750.00.
• Location: Remote, USA.