Medical Monitor - Ophthalmology

About the role

The primary objective for our Medical Monitor is to provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training.

Responsibilities

• Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial.
• Reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
• Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
• Providing review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Ensuring activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations.
• Consulting with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments.
• Developing and/or reviewing operational, medical monitoring, and safety plans for studies.
• Leading and/or participating in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
• Generating safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• Writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• Responsible for the management of clinical data collection including documentation of product trials and analysis.
• Managing clinical protocols to support company’s product strategy, data collection, management, and final report development in compliance with appropriate standard operating procedures, regulatory and medical standards.
• May also be responsible for determining whether a product accomplishes the goal for which it was produced.

Qualifications

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in Ophthalmology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
• Minimum 5 years of direct experience in medical monitoring and/or clinical development and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.