Medical Monitor

Unclassified - Malvern, PA

Full-time - Mid Level

Malvern, PA

About the position

The Medical Monitor at Ocugen Opco Inc. plays a crucial role in providing unbiased, 24/7 medical guidance to investigators, clinical sites, and study operations teams for various products in clinical stages. This position is responsible for ensuring that all medical aspects of clinical trials are conducted in compliance with protocols and regulatory requirements. The Medical Monitor will provide therapeutic and compound training, offer medical guidance on protocol compliance, and assist in the coding of medical terms. Additionally, the role supports clinical safety and data management by reviewing data listings and may contribute to the writing of the final study report. Regular communication with the medical team, including medical teleconferences, is essential, as well as interfacing with sponsor medical groups throughout the studies. The Medical Monitor will clarify general protocol questions and provide medical guidance as required. They will answer medical safety and protocol questions directly from sites or through the Site Manager, respond to specific inclusion/exclusion criteria questions, and address safety inquiries from the site or local IRB/IEC. Participation in locally held investigator meetings is expected, along with interaction with Key Opinion Leaders (KOLs) for local advisory board support. The role also involves performing local adverse event reviews prior to DSMB reviews, assessing causality on all serious adverse events (SAEs) at a regional level, and following up with investigators for additional information or clarifications. Moreover, the Medical Monitor will write country or site-specific Informed Consent Forms (ICFs), provide input on site selection and country feasibility, and consult with Medical Directors and Sponsor Medical groups regarding medical questions related to the study indication. They will quickly identify safety issues, consult on unblinding trial participants, review laboratory values, and recommend protocol changes as necessary. The position requires participation in the development, review, and finalization of protocols, amendments, and Clinical Study Reports, as well as providing medical input into data collection tools and study plans. The Medical Monitor will also attend and lead medical monitoring teleconferences throughout the study as required.

Responsibilities

• Provide clarity on general protocol questions and medical guidance for protocols as required.
• Answer medical (safety & protocol) questions directly from sites or from the Site Manager (SM).
• Answer specific inclusion/exclusion criteria questions.
• Respond to safety questions from the site or local IRB/IEC.
• Attend, participate, and/or present in locally held investigator meetings.
• Interact with KOLs/Experts for local advisory boards support and participate in Global or Regional Advisory Boards.
• Provide medical expertise specific to a region.
• Perform local AE review that occurs prior to the DSMB review.
• Review and assess causality on all SAEs on a regional level.
• Follow up with the Investigator for additional information or clarifications as needed.
• Write country or site-specific Informed Consent Forms (ICFs).
• Provide site selection/country feasibility input.
• Consult Medical Director(s), Sponsor Medical group and/or Safety with regard to medical questions pertaining to the indication under study.
• Quickly identify safety issues as appropriate.
• Provide consultation on the unblinding of trial participants/site staff to subject treatment allocation.
• Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values as appropriate.
• Review protocol deviation data and recommend protocol changes as appropriate.
• Follow a study-specific medical monitoring plan if applicable.
• Provide medical review of study level data to identify gaps and areas requiring additional safety-related follow-up.
• Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required.
• Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.).
• Provide medical input into study feasibility, site selection and site initiations as required.
• Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required.

Requirements

• Medical Degree M.D./D.O. is required.
• Previous medical monitoring experience preferred.
• Minimum 3+ years of experience in the pharmaceutical industry in clinical development is required.
• Clinical data review experience is required.
• Safety evaluation experience is required.
• Experience in medical practice and fully trained in all aspects of clinical trials, GCP, and evaluation of adverse events is necessary.
• Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Ocugen, client company personnel and prospective sponsors.
• Advanced understanding of drug development process, ICH and Good Clinical Practices (GCP) is required.
• Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects.

Nice-to-haves

• Experience in gene therapy and vaccines product protocol requirements.