Medical Monitor, Medical Device CRO
Location
United States
Posted
27 days ago
Salary
0
Seniority
Senior
Job Description
Medical Monitor, Medical Device CRO
NAMSA
• 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.
Job 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
- Local travel may be required.
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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