Clinical Trial Manager - Remote

Overview

The Clinical Trial Manager will lead the operational aspects of clinical trials, ensuring that all deliverables are met according to timelines, budgets, and quality standards.

In Short

• Lead clinical trial operations and ensure timely progression of clinical development programs.
• Manage project timelines and vendor performance.
• Oversee clinical operations plans and budget.
• Participate in vendor selection and budget negotiations.
• Develop and implement operational strategies for clinical trials.
• Monitor and track clinical trial progress.
• Ensure compliance with regulatory guidelines.
• Prepare and lead team meetings with stakeholders.
• Contribute to the development of clinical protocols and documents.
• Support departmental objectives as assigned.

Requirements

• BS/BA or above in a scientific or health care discipline preferred.
• At least ten years of experience in managing global clinical trials.
• Knowledge of ICH GCP E6 R2 and GDPR requirements.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office Word and Excel.
• Experience in managing CROs and service providers.
• Ability to identify risks and develop mitigation strategies.
• Experience in rare/orphan disease areas is preferred.
• Self-motivated and able to thrive in a fast-paced environment.
• Willing to travel domestically and internationally up to 20% of the time.

Benefits

• Market-competitive compensation and benefits package.
• Flexible PTO.
• Access to learning and development resources.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.