MedTech Clinical Safety Manager

IQVIA MedTech brings together deep industry expertise, including the proven legacy of MCRA, to help medical device and diagnostics companies navigate the full product lifecycle. As a trusted CRO and strategic partner, we provide integrated solutions spanning regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine specialized MedTech expertise with IQVIA’s data, technology, and global capabilities to help clients make smarter decisions and bring innovations to patients and markets. Join IQVIA MedTech and help shape the future of MedTech.

Job Summary 

The MedTech Clinical Safety Manager is a client-facing role that coordinates the delivery of assigned medical device and combination product safety projects across clinical and post-market programs. Working with guidance from senior Clinical Safety leadership, this role manages day-to-day project execution, including timelines, deliverables, safety review committee activities, documentation, client communications, and cross-functional follow-up. The position helps ensure contractual commitments are met through accurate tracking, timely escalation, regulatory compliance, and consistent delivery of high-quality client work. 

Job Responsibilities 

• Manage day-to-day execution of assigned client safety projects across medical device clinical studies and post-market safety activities, with oversight from senior Clinical Safety leadership. 

• Develop and maintain project plans, timelines, deliverables, documentation requirements, meeting schedules, and action-item trackers for assigned safety projects and committee activities; proactively escalate risks, scope changes, resource needs, or potential delays. 

• Lead and coordinate Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) meetings, including scheduling meetings, preparing and distributing meeting materials, coordinating with committee members and internal/external stakeholders, facilitating meeting logistics, documenting meeting outcomes and decisions, and tracking action items through completion. 

• Collect, review, organize, and maintain safety documentation, including adverse event reports, product complaints, committee records, and safety tracking logs. 

• Support case intake, data entry, reconciliation, quality checks, and maintenance of safety records in accordance with internal procedures and regulatory requirements. 

• Prepare and maintain project status reports, utilization and delivery metrics, meeting materials, and presentations for internal and client-facing discussions. 

• Serve as a day-to-day contact for assigned project activities, participate in client meetings, communicate status and next steps, and support resolution of delivery issues under the guidance of senior Clinical Safety staff. 

• Collaborate with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, finance/resource partners, and project teams to coordinate resources, maintain delivery commitments, and support timely resolution of safety-related activities. 

• Support inspection and audit readiness by maintaining complete, accurate, and organized documentation and safety records. 

• Contribute to the implementation and refinement of safety processes, workflows, templates, and standard operating procedures. 

• Monitor project performance against scope, timelines, and quality expectations; identify routine operational issues and recommend practical improvements to enhance efficiency, client satisfaction, and compliance. 

• Maintain working knowledge of applicable FDA requirements, EU MDR, ISO 14155, medical device vigilance, and post-market surveillance requirements. 

• Participate in occasional early morning or evening meetings to support global teams and safety review committees, averaging approximately one meeting per week. Flexible scheduling may be used to accommodate these requirements. 

• Perform other duties and projects as assigned. 

Required Qualifications 

• Bachelor's degree in Nursing, Life Sciences, Health Sciences, Public Health, Biology, Biomedical Sciences, or a related field. 

• Minimum of 4 years of experience in clinical research, medical device safety, project coordination or management, healthcare, quality, regulatory affairs, or a related field. 

• Experience supporting CECs, DSMBs, or other independent safety review committees. 

• Experience coordinating client-facing projects, timelines, deliverables, meetings, and operational activities across multiple stakeholders. 

• Strong organizational and prioritization skills, with the ability to manage multiple assignments and deadlines. 

• Excellent verbal and written communication skills, with the ability to present information clearly to internal and external stakeholders. 

• Demonstrated attention to detail and ability to maintain accurate, inspection-ready documentation. 

• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook. 

• Ability to work effectively both independently and as part of a fast-paced, collaborative team. 

Preferred Qualifications 

• Experience supporting medical device clinical trials, clinical safety, complaint handling, quality, or regulatory activities. 

• Familiarity with safety databases, clinical trial management systems (CTMS), electronic Trial Master Files (eTMF), or medical device complaint handling systems. 

• Familiarity with adverse event reporting, medical device vigilance, post-market surveillance, or product complaint processes. 

• Working knowledge of Good Clinical Practice (GCP), FDA medical device regulations, ISO 14155, EU MDR, or related requirements. 

• Experience preparing project metrics, status reports, meeting documentation, or client-facing materials. 

• Experience working in a billable consulting, CRO, or professional-services environment with responsibility for client deliverables and contractual timelines. 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $86,000.00 - $214,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.