Clinical Trial Manager

Responsibilities

• Lead the day-to-day operational management of assigned clinical trials from protocol concept through the final Clinical Study Report (CSR).
• Apply operational expertise to optimize study design, site relations, and patient recruitment strategies specific to the target study populations.
• Manage and provide sponsor oversight of Contract Research Organizations (CROs) and third-party vendors to ensure deliverables meet quality standards and timelines.
• Partner with internal and external stakeholders to align study objectives and ensure integrated study plans are executed on time and within budget.
• Draft, review, and contribute to critical study-related materials, including protocols, Informed Consent Forms (ICFs), Clinical Monitoring Plans, site training materials, and lab/pharmacy manuals.
• Oversee site identification, selection, enrollment modeling, clinical supply planning, data cleaning, and preparations for database lock.
• Proactively identify project-specific risks, develop operational contingency plans, and escalate timeline, quality, or budget issues with clear recommendations.
• Review vendor invoices and support the tracking of individual trial budgets in close collaboration with finance and clinical operations leadership.
• Ensure global studies are implemented in strict compliance with local and international ICH GCP regulations and company policies.
• Conduct co-monitoring visits or oversight site visits as required to ensure data integrity and protocol compliance.
• Assist with the mentorship and operational guidance of junior clinical operations staff (e.g., CTAs or CRAs).

Requirements

• Minimum of 7 years of experience working in a clinical operations role, with a strong track record in day-to-day study management (Sponsor experience preferred).
• Proven operational experience running clinical trials in cardiopulmonary indications, with specific experience in Cystic Fibrosis (CF), or chronic cardiopulmonary and lung diseases highly desired.
• Bachelor’s degree in life science, nursing, or related scientific discipline required.
• Strong working knowledge of FDA, EMA, and ICH GCP guidelines governing the conduct of global clinical trials.
• Demonstrated experience in hands-on CRO and specialty vendor oversight.

Skills

• Excellent project management, organizational, and attention-to-detail skills, paired with strong verbal and written communication abilities.
• Ability to travel as needed for investigator meetings and site oversight visits.