Senior Clinical Trial Manager - Contract - Remote, US
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.
Primary Responsibilities:
The successful candidate will be involved overseeing operational strategy, timelines, budgets, quality, vendor management, risk mitigation, and inspection readiness. You will collaborate with cross-functional teams and external vendors to ensure efficient and compliant study delivery aligned with program objectives.
Skills & 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.
The Senior Clinical Trial Manager's responsibilities will be:
- 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.
If you are having difficulty in applying or if you have any questions, please contact Alex Kelly at a.kelly@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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