Clinical Trial Manager

Clinical Trial Manager

The Clinical Trial Manager leads the planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers, including first-in-human (FIH), single and multiple ascending dose (SAD/MAD), food effect, bioavailability/bioequivalence (BA/BE), human abuse potential (HAP), thorough QT (TQT), drug–drug interaction (DDI), and other early-phase studies. This role oversees end-to-end study operations, manages vendors and clinical partners, ensures regulatory compliance and inspection readiness, and collaborates closely with cross-functional teams to support clinical development objectives.

Responsibilities:

• Plan, execute, and deliver Phase 1 clinical studies in healthy volunteers, including FIH, SAD/MAD, food effect, BA/BE, HAP, TQT, DDI, and other early-phase trials.
• Develop and manage detailed study timelines, budgets, forecasts, and resource plans to ensure studies are delivered on time and within budget.
• Provide operational input into protocol development and study design, including feasibility assessments and risk mitigation strategies.
• Oversee contract research organizations (CROs), Phase 1 units, laboratories, and clinical vendors to ensure high-quality performance and adherence to study objectives.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, internal standard operating procedures (SOPs), and applicable global regulatory requirements.
• Partner with Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Biostatistics, Medical, Safety, and Clinical Supply teams to support study execution and development goals.
• Maintain inspection readiness throughout the study lifecycle and oversee eTMF quality, completeness, and timely filing of essential documents.
• Monitor study progress, enrollment, safety, data quality, and operational metrics, proactively identifying and addressing risks and issues.
• Support IND submissions, protocol amendments, regulatory inspections, audit readiness, study closeout, and clinical study report (CSR) activities.
• Participate in SOP development, process mapping, and other departmental initiatives to enhance operational efficiency.
• Mentor and develop Clinical Operations staff while promoting operational excellence, process improvements, and a culture of quality and accountability.
• Help prepare for safety review and data committee meetings in collaboration with senior clinical operations leadership.
• Support current senior clinical operations leaders in managing ongoing Phase 1 programs and related operational activities.
• Effectively multi-task across multiple studies or work streams while maintaining high standards of quality and compliance.
• Contribute as a strong team player, fostering collaboration and clear communication across internal and external stakeholders.

Essential

Skills:

• B.S., M.S., or Ph.D. in basic sciences.
• 10+ years of Clinical Operations experience within biotechnology, pharmaceutical, or CRO environments.
• Minimum of 3 years of direct experience managing Phase 1 studies in healthy volunteers.
• Recent Phase 1 study experience within the past couple of years.
• In-human clinical study experience; bioanalytical-only experience is not sufficient.
• Clinical Operations experience; pharmacology-only experience is not sufficient.
• Expertise in clinical trial management and subject safety oversight.
• Strong vendor management skills, including oversight of CROs, Phase 1 units, laboratories, and clinical service providers.
• Proficiency in clinical research and project management within early-phase trials.
• Deep understanding and competent application of SOPs, ICH guidelines, global regulations, ethics, and compliance standards.
• Ability to work effectively in a team environment and collaborate with cross-functional stakeholders.
• Ability to…