Senior Clinical Data Manager

About Us

About the Role

As the Senior Clinical Data Manager, you will play a critical role within the team initially supporting our program for Myasthenia Gravis (MG) and other programs as required.

Reporting to the Director, Data Sciences, you will be responsible for overseeing all clinical data management and related deliverables from start-up through close out of various clinical trials. This individual will independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data in support of study reports, publications and regulatory submissions. This position requires both the knowledge and experience to work within established clinical trial paradigms while embracing new approaches to support data aggregation and analysis in the advancement of patient care.

This is a great opportunity to join a phase II / III clinical-stage biotech company and have significant impact as we grow. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Responsible for relationships with Data Management partners (eg, CROs and vendors) from protocol development through database lock to ensure data are collected, reviewed and delivered with high quality, are on-time and within scope.
• Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation (SAEs, labs, other external data), medical coding, UAT testing, database lock and archival of DM documents.
• Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals
• Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the Trial Master File
• Other related duties as may be determined or assigned

Experience

• University degree required within a relevant discipline – Life Sciences experience is a plus
• Comprehensive understanding of DM related systems, technologies and standards
• Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management
• Self-motivated and able to work autonomously as well as within a high-functioning and collaborative team environment
• Highly organized and detail-oriented
• Strong verbal and written communication skills with the ability to build relationships internally and with external partners
• Highest levels of professionalism, confidence, personal values and ethical standards