Clinical Study Manager

Scorpion Therapeutics; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Liquidia is seeking a Clinical Study Manager to lead clinical operations for pulmonary hypertension programs. You will oversee study planning, vendor management with CROs and labs, site initiation, protocol development, and budget oversight while ensuring regulatory compliance.

You will collaborate with Medical, CMC, and QA teams, maintain documentation accuracy, monitor progress and data quality, and support regulatory inspections. Flexibility for remote work with travel may be required.

Qualifications

• Bachelor's degree with 5+ years in clinical research.
• Experience managing external vendors and clinical teams.
• Strong knowledge of GCP, FDA regulations, and clinical trial processes.

Responsibilities

• Oversee study planning and execution, vendor management (CROs, labs), site initiation, protocol development, budget management, and regulatory compliance.
• Lead cross-functional collaboration with Medical, CMC, and QA teams; ensure documentation accuracy; monitor study progress and data quality; support regulatory inspections.

Skills

Clinical study management

Regulatory compliance

Vendor management

Communication

Project coordination

Education

Bachelor's degree in Life Sciences

Tools

Project management tools

Job description

Role: Clinical Study Manager (CSM) leading clinical operations for Liquidia's pulmonary hypertension programs.

Responsibilities

• oversee study planning and execution, vendor management (CROs, labs), site initiation, protocol development, budget management, and regulatory compliance.
• Lead cross-functional collaboration with Medical, CMC, and QA teams; ensure documentation accuracy; monitor study progress and data quality; and support regulatory inspections.

Requirements

• Bachelor's degree with 5+ years in clinical research, including 2+ years in study management;
• experience managing external vendors and clinical teams;
• strong knowledge of GCP, FDA regulations, and clinical trial processes;
• excellent communication, organization, and problem-solving skills.

Preferred

• experience with pulmonary hypertension or biologics, strong vendor negotiation skills, and proficiency with project management tools.

HighValue

• clinical trial execution in a small biotech setting, managing Phase 1-3 pulmonary hypertension studies, vendor oversight, and regulatory compliance.

WorkSetup

• flexible, potentially remote with up to 30% travel.