Senior Clinical Data Manager - Remote

Overview

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.

In Short

• Oversee all clinical data management and related deliverables from start-up through close out of various clinical trials.
• Support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data.
• Responsible for relationships with Data Management partners (CROs and vendors).
• Oversight of outsourced study-related DM activities including CRF design and data reconciliation.
• Ensure data quality and timeliness of DM deliverables.
• Maintain data integrity in compliance with GCP and regulatory requirements.
• Work autonomously and within a collaborative team environment.
• Strong verbal and written communication skills required.
• Highly organized and detail-oriented.
• Build relationships internally and with external partners.

Requirements

• University degree required within a relevant discipline.
• Comprehensive understanding of DM related systems and standards.
• Knowledge of drug development and clinical research processes.
• Self-motivated and able to work autonomously.
• Highest levels of professionalism and ethical standards.

Benefits

• Opportunity to join a phase II / III clinical-stage biotech company.
• Significant impact as the company grows.
• Open to remote work.