Medical Monitor, Medical Device CRO

NAMSA

21h•Hybrid

About The Position

NAMSA, a pioneer in medical device safety testing, is seeking a Medical Monitor. With a history dating back to before FDA regulation of medical devices, NAMSA has been instrumental in shaping industry standards and is the premier provider of support throughout the product development lifecycle. Our vision is to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Our mission is to deliver best-in-class global MedTech development solutions through our people, expertise, and technology, guided by our core values: integrity, customer experience, talent development, agility, and collaboration.

Requirements

Doctor of Medicine degree with post-residency clinical experience.
Minimum of 3 years of experience in clinical research or medical monitoring, preferably with a Contract Research Organization and multiple classes of devices across various therapeutic areas, including but not limited to cardiovascular, neurology, orthopedics, and urology.
Experience with MedDRA coding, EDC systems, CEC adjudications, and DMC operations.
Experience with global safety event reporting, especially EU MDR
Must be able to work independently.
Must possess excellent verbal and written communication skills.
Strong organizational skills with attention to detail.
Ability to work in a fast-paced environment with multiple competing priorities
Proficiency in Microsoft Office and literature databases (e.g., PubMed, MedLine).
Strong understanding of GCP, ICH, FDA, and global regulatory requirements.
Demonstrate a high degree of personal and professional integrity.

Responsibilities

Comply with the Safety Team Roles and Responsibilities
Perform medical review and interpretation of adverse events and device deficiencies reported by clinical trial investigators
Ensure timely and accurate assessment of safety data in compliance with regulatory requirements, study protocols, and internal SOPs.
Write and review adverse event narratives, ensuring clinical accuracy and consistency. Determine relevant follow-up information and ensure completeness of adverse event documentation.
Utilize MedDRA for medical coding and ensure consistency with MedDRA Points to Consider.
Act as a Medical expert for coordination of CEC and DSMB activities and oversee preparation of materials for CEC, DSMB and/or other Committee reviews
Review clinical study data, adverse event reporting, and clinical study design, to safeguard the rights, safety and wellbeing of all trial subjects
Assess safety events, conforming to regulatory requirements and protocol-specific definitions.
Provide medical input into the design of clinical study protocols, including safety endpoints, inclusion/exclusion criteria, and risk mitigation strategies.
Oversee development of study-specific safety documents such as Safety Plan and CEC/DMC charter.
Review and contribute to clinical evaluation reports, clinical study reports, other aggregate safety reports, and regulatory submissions.
Advise on protocol amendments based on emerging safety data or regulatory feedback.
Attend project meetings
Attend and participate in internal meetings as scheduled.
Perform continual assessment of adherence to timelines for all groups involved.
Serve as in-house Medical Subject Matter Expert for NAMSA projects.
For assigned projects, maintain relationship with appropriate C-level / VP-level team member from sponsor side (this is separate from project management discussions which will be the responsibility of the NAMSA Project Manager).
Support business development by contributing to proposals, attending sales meetings, and presenting medical capabilities to prospective clients
Participate in client meetings, including kick-off and safety review meetings, and provide expert input on safety-related matters.
Serve as a clinical and scientific advisor to clients, offering strategic guidance on safety, regulatory, and clinical development issues.
Collaborate with biostatistics, regulatory, medical writing, and clinical operations teams to ensure alignment on safety deliverables.
Participate in the design, testing, and maintenance of electronic systems supporting safety services.
Mentor and coach safety associates and non-medical team members.
Develop and deliver training sessions on therapeutic areas, safety processes, and protocol-specific topics.
Support onboarding new hires and contribute to departmental knowledge-sharing initiatives.
Participate in internal and external audits, inspections, and quality assurance activities.
Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines.
Maintain and contribute to the development of SOPs, templates, and training materials.
Track and manage safety metrics and key performance indicators.
Support accurate invoicing and budget tracking for safety-related services.
Ensure timely documentation of hours and expenses in accordance with company policy.