Clinical Study Manager - Remote

Overview

The Clinical Study Manager will oversee, execute, and report on clinical study operations for Foresight Diagnostics’ research projects, ensuring quality and efficiency in accordance with timelines and budget.

In Short

• Implement and manage clinical study protocols and operational plans.
• Ensure compliance with GCP/ICH guidelines and regulatory requirements.
• Coordinate timelines with cross-functional teams to meet milestones.
• Provide oversight to study team members for deliverables.
• Train partners and internal team members on study protocols.
• Manage study materials including protocols and data collection forms.
• Oversee eTMF for compliance and inspection readiness.
• Lead meetings and track project progress.
• Support process improvement initiatives.
• Act as a subject matter expert and mentor.

Requirements

• Bachelor’s degree or equivalent in a scientific field.
• 5+ years of clinical trial experience in biopharmaceuticals or academic medical centers.
• 3+ years of experience leading project operational teams.
• Experience with Clinical Research Organizations (CRO) or biopharmaceutical companies.
• Knowledge of Good Clinical Practices and U.S. regulations.
• Working knowledge of FDA submission processes.
• International study experience and GDPR implementation.
• Experience with complex clinical data sets.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills.

Benefits

• Annual salary of $150,000 - $170,000 with bonus and equity offerings.
• Paid vacation, sick time, and parental leave.
• Medical, dental, vision, life, and disability coverage.
• Flexible spending accounts.
• 401k with company match.
• Professional development opportunities.
• High-impact problem-solving work environment.
• Equal opportunity employer.