Senior Clinical Trial Manager - Remote

Overview

The Senior Clinical Trial Manager has a high level of core competencies and technical skills that are applied within the management of clinical programs leading to registrational submissions of Biologic License Applications (BLAs).

The Senior Clinical Trial Manager position is a member of a cross-functional clinical team that has high-visible and dynamic input in a therapeutic indication of unmet medical need and orphan disease status.

In Short

• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables.
• Manage the implementation, on-time execution and conduct of clinical studies.
• Oversight of cross-functional study team members.
• Risk management and mitigation.
• Lead role in vendor identification/qualification/selection.
• Understanding of how to support and deliver the trial endgame.
• Critically assess data to detect trends and outliers.
• Ability to critically review and supervise multifunctional vendor groups.
• Ensure data integrity through routine data reviews.
• Effectively track and communicate program/study progress to Senior Management.

Requirements

• Bachelor’s degree with 6+ years of pharmaceutical or biotech-related/clinical research experience.
• Must have oncology experience or cell therapy.
• Demonstrated experience in managing phase 1-4 clinical trials.
• Experience in management of CROs.
• Excellent interpersonal and communication skills.
• Subject matter expert in US and Global Regulations and Guidance.
• Broad scope experience in data collection, monitoring, cleaning, and analysis.

Benefits

• Inclusive work environment.
• Equal opportunity employer.
• Reasonable accommodations available.