Senior Clinical Trial Manager

About the role

Join a collaborative team where your leadership will shape the successful delivery of pivotal clinical trials across multiple regions. Proclinical is seeking a Senior Clinical Trial Manager to lead the execution of global clinical studies from startup through closeout and clinical study reporting.

Responsibilities

• Plan, execute, and oversee global clinical trials from initiation to closeout.
• Act as the primary operational lead for assigned studies, ensuring cross-functional alignment and execution.
• Develop and manage study timelines, budgets, enrollment forecasts, risk mitigation plans, and performance metrics.
• Oversee CROs and external vendors to ensure adherence to scope, quality standards, timelines, and budget.
• Drive critical milestones such as site activation, enrollment, database lock, and study closeout.
• Review and approve study plans, vendor deliverables, and trial documentation for compliance with protocols, GCP, and regulatory requirements.
• Identify and address operational risks, implementing mitigation strategies as needed.
• Lead study team meetings and provide regular updates to stakeholders and senior management.
• Ensure Trial Master File (TMF) quality, completeness, and inspection readiness throughout the study lifecycle.
• Support regulatory submissions, audits, inspections, and Health Authority interactions.
• Contribute to process improvements and mentor junior team members.
• Collaborate effectively with global teams, investigators, CROs, and vendors across multiple regions.

Requirements

• Bachelor's degree in a scientific or health-related discipline (or equivalent).
• Experience in clinical research, including clinical trial management within a sponsor or CRO environment.
• Expertise in managing Phase 1 studies and standard clinical pharmacology package studies (e.g., First in Human, Drug-to-Drug Interaction, Bioavailability/Bioequivalence).
• Proven ability to independently lead global Phase II and/or Phase III clinical trials.
• Strong experience managing CROs, central vendors, and cross-functional study teams.
• Neuroscience/CNS clinical development experience preferred.
• Familiarity with inspection readiness, audits, and regulatory interactions is advantageous.