Medical Monitor

The MM is responsible for executing medical monitoring activities for the assigned studies. MM is an individual contributor. MM is expected to help execute clinical studies under the leadership of the Lead-MM which includes help in designing, implementing, conducting, monitoring and analysis of clinical studies.

Disease Expertise

• Maintains the working scientific and clinical knowledge in the specific disease area(s) of assignment.
• Maintains good knowledge of clinical study documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, and policies.

Cross-Functional Team Collaboration

• Provide scientific support to the Lead-MM and clinical study team.
• Participates in ongoing clinical study team and relevant sub-team meetings, other interactions and communications. Responsible for the presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Provides Strategic Medical Support / Medical Monitoring for Assigned Studies and Programs
• Acts as a medical monitor for assigned studies and serves as a clinical point of contact for cross-functional teams and program-level stakeholders.
• Performs or oversees various medical monitoring activities including the ongoing medical review of the study data as per the medical data review plan. Conducts clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medical inquiries.
• Performs onsite medical monitoring visit and provide visit report on time to Lead-MM and the sponsor.
• As needed/appropriate, visit the study site for inspection readiness, incidence investigation, site initiation/training, investigator meetings, etc.
• Works with a high level of autonomy, providing decision accountability for the project, owns escalations, and communicates effectively at all levels.
• Partner in the execution of the program and/or clinical study (during study set up, conduct, recruitment activities, closeout, and reporting) in collaboration with Lead-MM.

Prepare/review the clinical sections of the study and program-level regulatory documents created and amended for the study as delegated by the Lead-MM to ensure medical appropriateness:

• Preparation and start-up phase
• Protocol Element Document/ Study Synopsis
• Full protocol and its amendments
• Informed consent form and its amendments
• FAQ on participant eligibility or other medical issues and potential concerns during the execution of the Local study.
• Medical monitoring plan/medical review plan and its amendments.

Clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research associate training, study newsletters, communications to study sites, etc.)

Documents in which review by MM is clearly defined or delegated by the Lead-MM.

• Execute training for other less experienced clinical scientist(s) who handle medical inquiries from the clinical operation team, site teams, investigators, etc.

Execution phase

• Execute responses to medical inquiries.
• Support Lead-MM in periodic medical coding reviews medical terms, medications, etc.
• As needed/appropriate, support Lead-MM in the review of safety narratives and other safety-related guidelines and documentation.

Close-out phase

• Review of the coding of medical terms that are used for the CSR.
• Documents in which review by MM is clearly defined or delegated by the Lead-MM.
• Perform an eligibility review of the potential study participants for the assigned study.
• May provide additional support with site training, as needed, or requested.

Perform an eligibility review of the potential study participants for the assigned study. May provide additional support with site training, as needed, or requested.