Clinical Trial Manager

The Clinical Trial Manager (CTM) is responsible for the day-to-day operational execution and management of assigned clinical studies in the Rare Disease portfolio. This role focuses on planning, initiating, executing, and closing clinical trials with operational excellence. Key activities include driving study timelines, tracking milestones, managing vendors and CROs, and proactively identifying and mitigating operational risks. The CTM ensures all studies are conducted in compliance with ICH GCP guidelines, company SOPs, and within the planned timeline and budget. This role serves as a primary operational point of contact for the cross-functional study team and key vendors.

Responsibilities:

• Study Execution: Lead the day-to-day operational management of assigned clinical trials from protocol concept through the final Clinical Study Report (CSR).
• Therapeutic Focus: Apply operational expertise to optimize study design , site relations, and patient recruitment strategies specific to the target study populations.
• Vendor Oversight: Manage and provide sponsor oversight of Contract Research Organizations (CROs) and third-party vendors to ensure deliverables meet quality standards and timelines.
• Cross-Functional Collaboration: Partner with internal and external stakeholders to align study objectives and ensure integrated study plans are executed on time and within budget.
• Study Documentation: 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.
• Site & Trial Operations: Oversee site identification, selection, enrollment modeling, clinical supply planning, data cleaning, and preparations for database lock.
• Risk Management: Proactively identify project-specific risks, develop operational contingency plans, and escalate timeline, quality, or budget issues with clear recommendations.
• Budget Tracking: Review vendor invoices and support the tracking of individual trial budgets in close collaboration with finance and clinical operations leadership.
• Compliance: Ensure global studies are implemented in strict compliance with local and international ICH GCP regulations and company policies.
• Site Monitoring: Conduct co-monitoring visits or oversight site visits as required to ensure data integrity and protocol compliance.
• Team Support: Assist with the mentorship and operational guidance of junior clinical operations staff (e.g., CTAs or CRAs).

Requirements:

• Experience: 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).
• Therapeutic Expertise: Proven operational experience running clinical trials in cardiopulmonary indications, with specific experience in Cystic Fibrosis (CF), or chronic cardiopulmonary and lung diseases highly desired.
• Education: Bachelor's degree in life science, nursing, or related scientific discipline required.
• Regulatory & Compliance: Strong working knowledge of FDA, EMA, and ICH GCP guidelines governing the conduct of global clinical trials.
• Vendor Management: 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.
• Travel: Ability to travel as needed for investigator meetings and site oversight visits.