The Medical Monitor (MM) is responsible for the review of the adverse events and product experiences reported within a clinical trial. The MM ensures the appropriate reporting of events to the Clinical Development Department and applicable Regulatory Authorities throughout the life of the trial. The MM acts as the liaison between the Safety department and all other internal departments, as well as to external entities such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated with the trial. The primary role of the Medical Manager is to support the the clinical department in all medical actvities.
The MM is expected to take full ownership on leading medical activities of the clinical study.
- Participate in protocol review for safety input, such as requirement of an EC/IRB or DMC/DSMB, adverse event reporting requirements, and endpoint determination
- Medical monitoring of clinical studies
- Approve subject eligibility
- Responsible for DMC/DSMB meetings, safety committee meeting, including member selection
- Responsible for the reconciliation of serious adverse events between different databases
- Assist with all activities related to establishing and managing all safety-related processes
- Review all safety related data for various clinical trials
- Review clinical safety databases, assist sites with subject evaluation and protocol adherence, and support in preparation of safety reports
- Serve as the main liaison between the different bodies involved in the safety process, i.e. between the DMC/DSMB, IRB/EC, CRO, investigators, and study team
- Support preparation of periodic safety reports to the FDA and IRB/ECs; support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other ad hoc reports documents as needed to support formal (PMA) regulatory filings
- Participate in clinical study design and planning
- Develop, coordinate and complete clinical study training for all staff involved with a clinical study
- Internal contact with applicable departments regarding the activities of the clinical trial/s
- External contact with applicable committees (e.g., IRB/EC, DMC/DSMB & CROs) regarding the activities of the clinical trial/s.
- Provide input as a medical expert, in any function within the company or in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CMC, Research, Translational Medicine, Global Medical Affairs, Legal, Patents, etc.), and internal decision boards.
PROFESSIONAL SKILLS AND BASIC QUALIFICATIONS
- 2 years of experience as a medical monitor
- High level of written and spoken Hebrew and English
- Excellent communication skills
Please email CV to hr@BioLineRx.com