Clinical Research Manager III (Remote Position)

Lead and manage all aspects of clinical trials, including planning, conducting, reporting, and ensuring compliance with regulatory standards. Responsible for team leadership, budget management, protocol development, and collaboration with cross-functional teams in a global setting.

Location: Remote (US)

Responsibilities

• Lead the Clinical Trial Team responsible for planning, conducting, and reporting clinical trials.
• Author protocols with scientific rigor and quality.
• Ensure efficient trial conduct with seamless execution and timely reporting.
• Manage and matrix supervise the global multidisciplinary Clinical Trial Team.
• Contribute to protocol development and collaborate with Medical Advisors.
• Ensure quality and timely execution of clinical trials within timeline and budget.
• Forecast trial resource needs and manage trial budgets.
• Write scientifically rigorous protocols and lead site and country selection.
• Ensure investigational product supply.
• Manage health authority and IRB/IEC submissions and approvals.
• Prepare auxiliary documents such as manuals, informed consent templates, and analysis plans.
• Define outsourcing specifications and work with procurement to identify vendors.
• Define scope of work and oversee vendor conduct.
• Implement standard data collection modules and approve deviations.
• Track trial progress and milestones.
• Resolve issues and escalate when necessary.
• Ensure data quality review, cleaning, and database lock.
• Report results to management and teams.
• Lead team meetings and document minutes.
• Contribute to regulatory documents and submissions.
• Implement best practices and standards for trial management.

Requirements

• Ability to establish clear directions and set objectives.
• Strong leadership and communication skills.
• Organizational awareness and cross-functional operation skills.
• Ability to embrace change and manage projects effectively.
• Customer and quality focus.
• Scientific thinking to identify bias and validity issues.
• Experience in conducting clinical studies independently.
• Proactive issue identification and resolution skills.
• Solid understanding of clinical trial regulations (GCP, FDA, EMA, ICH, ISO).