Medical Monitor, Medical Device CRO

Benefits

Additional Information

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: - 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. Qualifications & Technical Competencies: - 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