Clinical Trial Manager

Job Summary

Managing clinical trials from vendor selection to Clinical Study Report completion, the full-time Clinical Trial Manager will ensure timely and budget-compliant execution of trials while collaborating with internal R&D and external CRO partners in a remote working environment.

Key Responsibilities

• Oversee the management of clinical trials, ensuring compliance with ICH/GCP standards and timely completion of activities
• Lead the identification, evaluation, and oversight of clinical trial sites, including the creation of study-specific monitoring tools and documents
• Provide ongoing study data reviews and manage trial-level quality risk management while supporting cross-functional teams in developing study documents

Required Qualifications

• B.A./B.S. in life sciences or equivalent
• Minimum of 5 years of clinical research experience in the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials
• Experience in inflammation and/or immunology is strongly preferred
• Strong working knowledge of FDA/ICH guidelines and clinical study conduct from start-up through close-out
• Experience with informed consent development and EU CTR