Provide input into the design and conduct of clinical trials
Reviewing and/or generating key study documents
Assessing and interpreting safety data
Contributing to investigator, other site staff and clinical study team training
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
Providing review of study protocols and on-going medical oversight of clinical trials
Consulting with internal and external stakeholders in the development of clinical trial design and conduct
Developing and/or reviewing operational, medical monitoring, and safety plans for studies
Lead and/or participate 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, to ensure that the reporting of SAEs is current and complete
Responsible for the management of clinical data collection including documentation of product trials and analysis
Manages 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.

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
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.

eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug benefits
flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
life insurance and death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Senior Director – Medical Monitor, Ophthalmology

Key skills