MedTech Clinical Safety Manager

IQVIA•Washington, DC

2d•$86,000 - $214,800

About The Position

The MedTech Clinical Safety Manager is a client-facing role coordinating assigned medical device and combination product safety projects across clinical and post-market programs. With guidance from senior Clinical Safety leadership, the manager oversees day-to-day project execution, including timelines, deliverables, safety review committee activities, documentation, client communications, and cross-functional follow-up. The role helps ensure contractual commitments are met through accurate tracking, timely escalation, regulatory compliance, and consistent delivery of high-quality client work. The position coordinates Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) activities; maintains safety documentation and records; supports case intake, data entry, reconciliation, and quality checks; and prepares project reports, metrics, meeting materials, and presentations. It collaborates with internal functions and project teams, supports audit and inspection readiness, and contributes to improving safety processes and workflows. The role requires maintaining working knowledge of applicable FDA requirements, EU MDR, ISO 14155, medical device vigilance, and post-market surveillance requirements. Occasional early-morning or evening meetings support global teams and safety review committees, averaging approximately one meeting per week; flexible scheduling may be used to accommodate these meetings.

Requirements

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, including 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.

Nice To Haves

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.

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; proactively escalate risks, scope changes, resource needs, or potential delays.
Lead and coordinate CEC and DSMB meetings, including scheduling, preparing and distributing materials, coordinating stakeholders, facilitating logistics, documenting 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 senior Clinical Safety staff guidance.
Collaborate with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, finance/resource partners, and project teams to coordinate resources, maintain delivery commitments, and resolve safety-related activities in a timely manner.
Support inspection and audit readiness by maintaining complete, accurate, and organized documentation and safety records.
Contribute to 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 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.