Medical Monitor

The Medical Monitor (MM) serves as the medical expert for assigned clinical trials. S/he is responsible for providing input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assess and interpret safety data, and contribute to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical and protocol related questions. S/he will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team.

The Medical Monitor will also assist the department head in the development and execution of patient safety and pharmacovigilance activities. S/he must provide oversight of study patients’ safety matters. S/he works closely with other departments, sponsors, and investigator sites to ensure that proper plans are in place to ensure proper medical oversight.

Key Responsibilities

• Work as primary or back-up Medical Monitor for assigned clinical trials which includes being readily available to advise internal and external stakeholders on trial related medical questions or problems during the activation, enrolment to and/or conduct of the trial;
• Responsible for reviewing and coding 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;
• Provide 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;
• Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments;
• Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs;
• Develop and/or review operational, medical monitoring, and safety plans for awarded studies;
• Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection;
• Lead and/or participate in scientific and medical training to other Anova team members and outside clients, investigators, and other site staff as it pertains to assigned studies;
• Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB;
• Ensure activities related to SAEs are conducted in accordance with applicable SOP’s and regulations;
• Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete;
• Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events;
• Liaise with investigator to review AEs/SAEs on behalf of the Sponsor;
• Work within the Medical Affairs team to ensure compliance with applicable regulations and standard operating procedures;
• Assist in the development and maintenance of standard documents regarding safety and medical monitoring processes and procedures;
• Support and participate in other activities of other divisions in the Medical Affairs department as applicable, including but not limited to medical coding;
• Lead by example and model core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development;
• Demonstrate thought leadership and deep medical and clinical research expertise;
• Ensure your deep medical and clinical research experience influences the planning and delivery of Anova solutions and services to clients;
• Understand key industry trends that drive the need for major customer change;
• Maintain heightened awareness of current and predicted market trends and developments in clinical research, and develop strategies to respond to such trends;
• Lead, coach and provide guidance and mentoring to Anova colleagues.Foster a culture of excellence, collaboration and continuous learning;
• Participate in the development and growth of the clinical and clinical research teams in the areas of clinical engagement and research governance, process management and operational excellence;
• Provide clinical assurance to the development of the Anova clinical research product suite.

Education

• PhD and/or MD degree.

Experience

• Doctor of Medicine (MD) with strong leadership skills including a minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role;
• Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment;
• Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research;
• Excellent project management skills, written and oral communication, organizational, and interpersonal skills;
• Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities;
• Action-oriented and resilient in a fast-paced environment and with the ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions in a matrixed environment;
• Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members;
• Ability to mentor and delegate;
• Substantive expertise in leading clinical research management and research service transformation. Anova’s clinical function will include roles that have a demonstrable track-record of success in clinical research planning, design and delivery, and workflow optimisation.
• Excellent judgemental and decision-making capabilities.
• Flexibility to acquire additional competencies and skill sets as mandated by the changing needs of the organisation.
• Strong conceptual thinker with ability to integrate input from diverse fields of research, clinical services and drug development.