Medical Monitor

Job Purpose

Ocugen’s Medical Monitor is responsible for providing unbiased, 24/7, medical guidance to investigators, clinical sites, and study operations teams for our various products within clinical stages. Provides therapeutic and compound training, medical guidance on protocol compliance and coding of medical terms, supports clinical safety and data management by reviewing data listings, and may also assist with the writing of the final study report. The role may provide regular communication to the medical team (including medical teleconferences), and interfaces with sponsor medical groups throughout studies.

 

Duties and 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 (Expert Management) 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
• May include discussions with regarding the local practice of medicine vs. the study protocol
• 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

Qualifications Qualifications                                                                                                                                                                                                                              

• 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
• 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
• Provide internal training to Ocugen’s operational teams on gene therapy and vaccines product protocol requirements etc., as needed to support execution of client studies
• Assist with the development of investigator training and meeting support materials
• Attend and present at investigator meetings and CRA training meetings

 

Working Conditions

This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of normal business hours such as weekend hours as patients' adverse events can be reported during that time.

Physical Requirements

This is a largely sedentary role.

 

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,
current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.