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, 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.
• Managing clinical data collection including documentation of product trials and analysis.
• Supports new and ongoing clinical research and clinical trials and ensures efficient and timely processing of confidentiality agreements and clinical agreements.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.

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.
• 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.
• Proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.