Job Summary
The MedTech Safety Project Lead provides operational, project coordination, and administrative support to the Clinical Safety team in the management of medical device and combination product safety activities across clinical and post-market programs. This role serves as a key coordinator of safety operations and independent safety review committees, ensuring accurate tracking, documentation, and communication of safety information while supporting project execution, regulatory compliance, and cross-functional collaboration.
Job Responsibilities
- Provide day-to-day operational and administrative support to the Clinical Safety team across medical device clinical studies and post-market safety activities.
- Serve as the primary operational coordinator for assigned safety projects and committee activities, ensuring deliverables, timelines, and documentation requirements are successfully executed.
- Assist with management of independent safety review committees (Clinical Events Committees (CECs) and Data Safety Monitoring Boards (DSMBs)), including preparation of meeting materials, meeting participation, and appropriate documentation of meeting outcomes.
- Coordinate safety-related project tracking, timelines, documentation, meeting scheduling, and action item follow-up.
- Support the collection, review, and maintenance of safety documentation, including adverse event reports, product complaints, and safety tracking logs.
- Assist with case intake, data entry, quality checks, and organization of safety records in accordance with internal procedures and regulatory requirements.
- Prepare meeting materials, project status reports, metrics, and presentations for internal and client-facing discussions.
- Participate in client meetings and support preparation of client-facing safety updates, reports, metrics, and presentations.
- Partner with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, and project teams to ensure timely communication and resolution of safety-related activities.
- Support inspection and audit readiness activities through maintenance of accurate documentation and safety records.
- Assist with implementation and refinement of safety processes, workflows, and standard operating procedures.
- Participate in safety team meetings and contribute to process improvement initiatives designed to enhance operational efficiency and compliance.
- Maintain awareness of applicable FDA, EU MDR, ISO 14155, vigilance, and post-market surveillance requirements governing medical device safety activities.
- Perform other duties as assigned.
Job Qualifications
Required Qualifications
- Bachelor's degree in Nursing, Life Sciences, Health Sciences, Public Health, Biology, Biomedical Sciences, or a related field.
- Minimum 2 years of clinical, healthcare, clinical research, medical device, or patient care experience.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
- Excellent verbal and written communication skills.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
- Demonstrated attention to detail and ability to maintain accurate documentation.
- Ability to work effectively in a fast-paced, collaborative environment .
- Ability to participate in occasional early morning or evening meetings to support global teams and safety review committees. Flexible scheduling may be utilized to accommodate these requirements.
Preferred Qualifications
- Experience supporting medical device clinical trials, clinical research, safety, quality, regulatory affairs, or complaint handling 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.
- Understanding of Good Clinical Practice (GCP), FDA medical device regulations, ISO standards, or MDR requirements.
- Experience coordinating projects, meetings, or operational activities across multiple stakeholders.
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 $51,800.00 - $129,600.00. 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.