• , US

Company:  Confidential

Job Title: Medical Monitor

Job Number: 81521

Location: , US

Job Description

The Medical Monitor oversees clinical trials and reviews clinical and scientific documents for Medical Affairs, Clinical Development, Regulatory, and Clinical Operations teams. Responsibilities include supporting a metabolic diseases program by reviewing or generating study documents, assessing safety data, and contributing to training for investigators, site staff, and the clinical study team. The role requires applying scientific knowledge, analytical skills, and technical writing to produce high-quality, consistent, and timely deliverables.


* Serve as primary Medical Monitor for assigned clinical trials, providing expertise on trial-related medical issues. * Develop and review medical monitoring and safety plans for awarded studies. * Finalize safety narratives, analyze similar events, and contribute to safety trend analysis. * Review safety sections of charters, plans, and reports for committees like CEC and DSMB. * Support safety sections of regulatory annual reports. * Conduct literature reviews for regulatory submissions. * Consult with stakeholders and experts on trial design and protocol drafting. * Collaborate with clinical teams to develop or edit clinical documents. * Assist in regulatory submissions, including briefing documents and safety summaries. * Ensure compliance with regulations, company policies, and guidelines. * Approach all tasks with a proactive attitude and fulfill additional duties as assigned.

Required Skills

* MD or equivalent required * Minimum 5 years of medical device industry experience, ideally in medical monitoring * Experience in biotech, pharmaceutical, and/or medical device industries preferred * Prior vocational experience (Co-Ops, Internships, Fellowships) a plus * Proficiency with ICH-GCP guidelines and other regulatory rules * Knowledge of medical terminology, clinical trials, and research * Ability to interpret and organize clinical and scientific data * Experience in type 2 diabetes, metabolic disorders, and/or medical devices preferred * Familiarity with electronic documentation management systems preferred * Strong interpersonal and communication skills (written and verbal) * Patient-focused approach * Ability to work independently or in a team on multiple projects with high quality * Successful track record in dynamic organizations * Demonstrated innovation and problem-solving skills * Ability to lead projects with urgency and quality * Hands-on experience and expertise * Proven team-player in small working environments * Highly organized and detail-oriented with a commitment to quality * Excellent communication skills for technical and user-friendly documentation * High standards of professionalism, confidence, and ethical standards * Up to 25% travel may be required

Application Deadline: 2024-08-12


Apply for job

To apply for this job please visit jobrxiv.org.