Medical Monitor, Medical Device CRO

This is a fully remote position, open to applicants in United States.

📋 Description

• Adhere to the roles and responsibilities of the Safety Team.

• Conduct medical reviews and interpret adverse events and device deficiencies reported by clinical trial investigators.

• Ensure prompt and precise evaluation of safety data in accordance with regulatory standards, study protocols, and internal SOPs.

• Draft and review narratives for adverse events, ensuring clinical precision and consistency while determining relevant follow-up information for complete documentation.

• Utilize MedDRA for medical coding and ensure adherence to MedDRA Points to Consider.

• Serve as a medical expert in coordinating Clinical Event Committee (CEC) and Data Safety Monitoring Board (DSMB) activities, overseeing the preparation of materials for reviews by CEC, DSMB, and/or other committees.

• Review clinical study data, adverse event reports, and clinical study designs to protect the rights, safety, and well-being of all trial participants.

• Evaluate safety events in line with regulatory mandates and protocol-specific definitions.

• Provide medical insights into the design of clinical study protocols, including safety endpoints, inclusion/exclusion criteria, and risk mitigation strategies.

• Oversee the creation of study-specific safety documents like Safety Plans and CEC/DMC charters.

• Review and contribute to clinical evaluation reports, clinical study reports, aggregate safety reports, and regulatory submissions.

• Counsel on protocol amendments in response to emerging safety data or regulatory feedback.

• Participate in project meetings and scheduled internal meetings.

• Continuously assess adherence to timelines across all involved groups.

• Act as the in-house Medical Subject Matter Expert for NAMSA projects.

• For assigned projects, maintain relationships with relevant C-level or VP-level contacts from the sponsor side separate from project management discussions led by the NAMSA Project Manager.

• Assist in business development by contributing to proposals, attending sales meetings, and showcasing medical capabilities to prospective clients.

• Engage in client meetings, including kick-off and safety review meetings, offering expert input on safety-related issues.

• Function as a clinical and scientific advisor to clients, providing strategic counsel on safety, regulatory, and clinical development matters.

• 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.

• Create and deliver training sessions on therapeutic areas, safety processes, and protocol-specific topics.

• Assist in onboarding new hires and contribute to initiatives for departmental knowledge sharing.

• Take part in internal and external audits, inspections, and quality assurance activities.

• Ensure compliance with Good Clinical Practice (GCP) and relevant regulatory guidelines.

• Maintain and assist in developing SOPs, templates, and training materials.

• Monitor 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.

⛳️ Requirements

• Medical Doctor (MD) degree with post-residency clinical experience.

• At least 3 years of experience in clinical research or medical monitoring, ideally with a Contract Research Organization and across multiple device classes in various therapeutic areas, including but not limited to cardiovascular, neurology, orthopedics, and urology.

• Proficient in MedDRA coding, EDC systems, CEC adjudications, and DMC operations.

• Experience with global safety event reporting, particularly EU MDR.

• Local travel may be necessary.

• Ability to work independently.

• Exceptional verbal and written communication skills.

• Strong organizational abilities with a keen attention to detail.

• Capacity to function in a fast-paced environment with multiple competing priorities.

• Proficiency in Microsoft Office and literature databases (e.g., PubMed, MedLine).

• Solid understanding of GCP, ICH, FDA, and global regulatory requirements.

• Exhibit a high level of personal and professional integrity.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Opportunities for professional development.