Clinical Trials Operations Manager

4 days ago

Bethesda, Maryland, United States Technical Resources International Full time
Job Title

Clinical Trials Operations Manager

Job Summary

We are seeking a highly skilled Clinical Trials Operations Manager to join our team at Technical Resources International. The successful candidate will be responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget.

Key Responsibilities
  • Project Planning and Management: Assist with plans and management of day-to-day operational aspects of one or more assigned programs/projects or tasks, including planning/timelines, budgeting/resourcing, and vendor management/interfacing.
  • Protocol Implementation: Responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments (if required).
  • Stakeholder Management: Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
  • Reporting and Presentations: Lead and/or actively participate in the conduct of clinical team meetings. May prepare sections for monthly, quarterly, and annual reports; and, present at internal and/or scientific meetings.
  • Quality and Compliance: Ensure project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsors-specific requirements.
  • Team Leadership: Provided oversight and mentorship to staff in the delivery of quality work and performance, as per task order and/or project deliverables, may include line management responsibility and staff hiring.
Requirements
  • Regulatory Knowledge: Working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH (R2) guidelines and hands on regulatory, clinical operations, or clinical trial monitoring experience.
  • Leadership Skills: Demonstrated ability to take a leadership role and drive quality progress.
  • Communication Skills: Strong presentation, problem-solving, and conflict resolution skills.
  • Task Management: Demonstrated task management skills, with senior team member oversight.

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