Clinical Trial Manager (CRO & Device)

Clinical Trial Manager
Role Overview

The Clinical Trial Manager (CTM) provides operational leadership for the successful execution of clinical trials within Emergent CRO’s agile, MedTech-focused environment. This role is responsible for managing day-to-day study activities to ensure trials are delivered on time, within scope and budget, and in full compliance with regulatory standards from study start-up through closeout.

Acting as a key liaison between Sponsors, investigators, vendors, and internal teams, the Clinical Trial Manager drives alignment, maintains clear communication, and ensures study momentum. This position plays a critical role in translating strategy into execution while supporting team collaboration and delivering high-quality outcomes aligned with Emergent’s mission of advancing healthcare innovation through client-centered research.
Key Responsibilities

• Manage the day-to-day planning, execution, and oversight of clinical trials (single-site, multi-center, or combination studies) across diverse therapeutic areas.
• Serve as a primary point of contact for Sponsors, ensuring consistent communication, responsiveness, and strong working relationships.
• Coordinate site and vendor activities, timelines, and deliverables to ensure operational efficiency and study progress.
• Develop and maintain study timelines, tracking tools, and operational plans to support milestone achievement.
• Monitor study performance and proactively identify risks, escalating issues and driving solutions when needed.
• Ensure compliance with ICH-GCP, FDA regulations, MDR, and internal SOPs.
• Support budget tracking, resource planning, and financial oversight in collaboration with leadership.
• Maintain organized documentation and reporting to ensure inspection readiness and regulatory compliance.
• Contribute to continuous process improvement efforts that enhance quality, efficiency, and consistency across studies.

Training & Team Support

• Support and guide Project Coordinators and other team members in executing study activities effectively.
• Reinforce best practices in communication, documentation, and operational execution.
• Assist with onboarding and training of new staff to ensure consistency in study management and expectations.
• Promote a collaborative team environment focused on accountability, reliability, and continuous improvement.

Team & Organizational Support

• Collaborate cross-functionally with Regulatory Affairs, Data Management, Biostatistics, and Clinical Monitoring teams to ensure seamless study execution.
• Provide regular study updates to leadership, identifying risks, trends, and opportunities for improvement.
• Participate in company initiatives that strengthen operational processes, delivery performance, and team culture.
• Represent Emergent CRO professionally in Sponsor meetings and internal discussions.
• Embody Emergent’s Built to Care philosophy through integrity, accountability, and respectful communication.

Required Skills & Competencies

• Strong organizational and time-management skills to support multiple concurrent studies.
• Effective communication and relationship-management abilities.
• Ability to manage timelines, priorities, and operational details in a fast-paced environment.
• Proactive problem-solving and risk identification skills.
• Working knowledge of clinical regulations (GCP, FDA CFRs, MDR).
• High attention to detail and ability to maintain accurate documentation.
• Proficiency in Microsoft Office and clinical trial management systems.

Education & Experience

• Bachelor’s degree in a scientific or healthcare discipline.
• Typically 5–8 years of experience in clinical research or clinical trial operations.
• Experience supporting or managing multi-center clinical trials within a CRO or Sponsor setting.
• MedTech or medical device trial experience strongly preferred.
• Experience coordinating cross-functional teams and managing study deliverables.
• Willingness to travel up to 5% for Sponsor or internal meetings.

Emergent CRO Core Values
At Emergent CRO, we are Built to Care for our clients, colleagues, and the patients we serve.

• Do the Right Thing Always — Act with integrity, transparency, and respect.
• Own It, Deliver It — Take accountability and deliver with excellence.
• Commitment to Continuous Growth — Pursue learning to elevate ourselves and the organization.
• Solutions Over Problems — Focus on progress and constructive outcomes.