Clinical Trial Manager (CRO & Device)
Clinical Trial ManagerRole OverviewThe 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 ResponsibilitiesManage 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 SupportSupport 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 SupportCollaborate 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 & CompetenciesStrong 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 & ExperienceBachelor’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 ValuesAt 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.