Sr Clinical Data Manager

Role Summary

The Senior Clinical Data Manager is a support-level team member and provides subject matter expertise in operational aspects of Clinical Data Management for assigned clinical trials. They are responsible for activities throughout the clinical study lifecycle and share accountability with the Clinical Data Lead.

Responsibilities

• Responsible for assigned activities throughout the study lifecycle, such as designing and testing CRFs, edit checks, reports, and listings; document creation; data cleaning; query management; and risk identification and mitigation.
• Act as the back up to the Clinical Data Lead, providing subject matter expertise and support to cross functional teams.
• Applies data strategy, confirms use of global standards, supports cross functional study team members, and assists in monitoring and reporting overall study progress.
• Accountable for comprehensive review of study data, ensuring all tasks are performed according to Biogen processes, regulatory guidelines, and study specific plans.
• Performs or oversees the reconciliation of data collected in EDC with other sources, such as the safety database and external vendor systems.
• Investigates issues and recommends solutions using experience, judgement, and precedent.
• Reviews study metrics and effectively communicates data topics across internal and external teams, escalating relevant issues for timely resolution.
• Contributes to the development of Data Management process, including new process creation, process improvement, and innovation.
• Supports the assessment of vendor quality and efficiency, including Data Management FSP team members and external vendor data providers.
• Participates in cross-functional collaborations, including study level activities and special projects or initiatives.

Qualifications

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