Clinical Trial Manager, Immunology

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the planning, execution, and management of clinical trials to ensure they are conducted efficiently, ethically, and in accordance with regulatory standards.

• Lead the creation and execution of clinical trial protocols, including site selection, strategies for patient recruitment, and the development of timelines.

• Oversee all facets of clinical trial operations, ensuring compliance with timelines, budgets, and regulatory obligations.

• Build and maintain robust relationships with clinical trial sites.

• Monitor trial progress, guaranteeing precise data collection, timely reporting, and compliance with Good Clinical Practice (GCP) standards.

• Recognize potential study risks and devise mitigation strategies to ensure favorable trial outcomes.

• Prepare and deliver updates to stakeholders, including internal teams and external partners.

⛳️ Requirements

• B.S. degree with a minimum of 6-8+ years of experience in managing clinical trials in the biotech or pharmaceutical sectors.

• Extensive experience in clinical study conduct from initiation to close-out, with expertise in global trial and CRO management.

• Proven experience in overseeing and managing phase II and III studies.

• Proficiency in timeline management.

• Strong leadership, decisive problem-solving, and effective decision-making skills required.

• Conduct document reviews in relevant systems with a focus on inspection readiness.

• Solid understanding of relevant GCPs and regulations from the FDA, EMA, and MHRA.

• Demonstrated experience with various EDC, CTMS, and eTMF systems (e.g., Veeva, Agatha).

• Experience with operational financial tracking systems is a plus.

• Demonstrated proficiency in MS Office applications, including MS Word, Excel, and PowerPoint.

• Familiarity with Smartsheet.

• Ability to work effectively with minimal supervision and manage multiple activities to ensure deliverables across all trials.

• Exceptional written and verbal communication skills.

🏝️ Benefits

• Travel up to 25%.

• Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

• Equal Opportunity Employer.