Ophthalmology Medical MonitorSME (Project-Based)
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Job Location:
Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS is a award-winning data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit follow MMS on LinkedIn.
This role is a project-based consulting opportunity to conduct medical monitoring on an as-needed basis. This is not a full-time position.
Role & Responsibilities
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit follow MMS on LinkedIn.
This role is a project-based consulting opportunity to conduct medical monitoring on an as-needed basis. This is not a full-time position.
Role & Responsibilities
- Provide medical input into the development and execution of study documents and plans such as study protocol IB SMP DMP SAP Lab manuals etc.
- Provide medical expertise to sponsors in the drug development process
- Provide significant expertise as primary medical reviewer of individual adverse event reports clinical and safety documents
- Lead safety activities on assigned product(s) that may include interactions with other functional groups inthecompany
- Responsible for medical monitoring tasks which may include:
- Eligibility review
- Review of safety-related protocolrelated deviations
- Review of safety data
- Develop Medical Monitor Plan
- Participation in medical monitoring and/or safety review meetings as needed
- Medical management of queries
- Medical coding review
- Maintain records and logs
- Medical review of study documents
- Responsible for strategies in pre and post marketing risk management as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
- Responsible for strategies in monitoring and analysis of cumulative safety information
- Maintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reporting
- Medical degree required (MD or equivalent)
- Specialty in Ophthalmologyor comparable experience inOphthalmology
- 5 or more yearsof clinical experience and/ or research experience required
- Relevant experience in safety physician safety committee membershipmedical monitoring and/or medical reviewer in pharmaceutical industry
- Excellent scientific writing skills
- Ability to understand clinical data
- Proficiency with MS Office applications
- Good communication skills
- Strong knowledge of current regulatory practices and domestic and international regulations
Required Experience:
Senior IC
Key Skills
About Company
MMS Holdings is a leading global data-focused CRO (Clinical research organization) & technology enabled clinical research and health data analytics solution company that supports the pharmaceutical, biotech, and medical device industries.
