Senior Clinical Data Manager - Remote

Overview

The Senior Clinical Data Manager is responsible for performing end to end Data Management activities. Participates as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance.

In Short

• Leads a large clinical study or a series of related studies with minimal guidance.
• Represents Data Management at study management team meetings.
• Provides mentoring and training to lower-level Data Management staff assigned to his/her studies.
• Manages and monitors the progress of data management activities with CROs or other vendors.
• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Performs detailed reviews of eCRF data requirements.
• Interacts with CRAs, programmers, and statisticians in designing eCRFs.
• Leads the development of data edit check specifications.
• Coordinates the design and testing of Electronic Data Capture (EDC) systems.
• Performs database lock and freeze activities per company SOPs.

Requirements

• Bachelor's Degree or equivalent experience in the scientific/healthcare field with a minimum of 8 years of experience.
• Good project management skills and a proven ability to multitask.
• Comprehensive understanding of regulatory guidelines and industry standards.
• Attention to detail and strong communication skills.
• Experience in working with oncology studies.
• Able to travel to off-site meetings as needed.
• Solid computer system and technical skills.
• Prior experience with Data Management systems and EDC systems is desirable.

Benefits

• Opportunity to work in a diverse and inclusive environment.
• Potential for professional growth and development.
• Engagement in meaningful work within the healthcare sector.