Clinical Trial Manager

About the role

The Clinical Trial Manager (CTM) leads the day-to-day operational execution of Phase I–IV clinical trials in strict compliance with FDA regulations, GCP, and ICH guidelines. This role acts as the central hub, cross-functionally coordinating internal teams, Contract Research Organizations (CROs), vendors, and clinical sites to keep studies on timeline, within budget, and inspection-ready.

Responsibilities

• Direct all operational aspects across study start-up, active conduct, and close-out
• Develop core trial documents, including study protocols, Informed Consent Forms (ICFs), Clinical Monitoring Plans, and operational SOPs
• Lead the evaluation, RFP process, and performance oversight for CROs, central labs, eCOA/IRT providers, and site monitoring services
• Track KPIs, review monitoring visit reports, and resolve operational bottlenecks
• Oversee site feasibility assessments, selection, activation, and investigator meetings
• Design patient enrollment and retention strategies to ensure recruitment targets are hit without compromising data quality
• Manage multi-million-dollar study budgets, approve vendor invoices, track pass-through costs, and handle change orders
• Ensure absolute compliance with FDA 21 CFR regulations, GCP, and local IRB requirements
• Maintain Trial Master File (TMF) completeness and lead audit/inspection readiness efforts
• Partner with Data Management, Safety/Pharmacovigilance, Biostatistics, and Medical Writing to facilitate timely database locks and Clinical Study Reports (CSRs)

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or related health discipline (Master’s or PharmD preferred)
• 5+ years in clinical research operations, including at least 2–3 years of direct study management experience within a sponsor company or CRO
• In-depth knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), ICH-GCP guidelines, and ClinicalTrials.gov registry maintenance
• Proficiency with EDC (e.g., Medidata Rave), CTMS, eTMF systems, IRT/IxRS, and Microsoft Office / Project

Preferred Qualifications

• SOCRA (CCRP) or ACRP (CP/CTM) certification