Medical Safety Monitor
The Medical Safety Monitor is responsible for the oversight of study safety including adverse events, protocol deviations and product experiences/complaints reported within a clinical trial. The Medical Safety Monitor ensures the appropriate reporting of the events to the Clinical Department and applicable Regulatory Authorities throughout the life of the trial. The Medical Safety Monitor acts as the liaison between the safety department and all other internal departments as well as to external partners such as CROs, the Clinical Events Committee and the DMC associated to the trial.
- Reviews and analyzes all safety related data for clinical trials including adverse events, protocol deviations and product experiences/complaints.
- Reviews and assist in creating narrative reports for notable clinical events in conjugation with Clinical Events Committee; assisting sites with subject evaluation and protocol adherence; and preparing safety reports to support regulatory notifications and filings.
- Serve as the liaison between the different bodies involved in the safety process i.e. between the CEC, DMC, CRO, Investigators, and Study Team.
- Lead safety work in an outsourced model with different safety responsibilities allocated to multiple organizations.
- Support preparation of periodic safety reports to the FDA, IRB/IECs and other competent authorities.
- Prepares presentations to the safety team in order to review and evaluate study safety data.
- 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 regulatory filings. Example, PMA.
SKILLS & EXPERIENCE
Bachelor’s degree or equivalent combination of education and experience. Masters, M.D., PH.D., RN, BSN, Nurse Practitioner or Physician Assistant degree (or the equivalent work experience) strongly preferred. Employee must have a strong clinical orientation and knowledge of diverse therapeutic categories. Minimum of 5-7 years of clinical research experience, preferably at least three years in Class III implantable Medical Device Safety.
- Thorough knowledge of 21 CFR, ICH and ISO regulations.
- Regulations/Guidelines governing the reporting of adverse events.
- Experience in participating in safety review processes.
- Strong written and verbal communication skills.
- Familiar with medical terminology and MedDRA.
- Organizational skills & ability to direct and manage projects.
- Ability to manage multiple priorities.
- Analytical, detail-oriented, and with ability to solve problems and multi-task.
- Excel, Word and Power Point proficiency
Candidate with experience in Heart Failure Class III implantable Medical Devices Clinical Studies who have thorough understanding of INR, BUN and Heart Failure are strongly preferred. A familiarity with pacemakers, Implantable Cardioverter-Defibrillator (ICD)/Pacing or stents or an equivalent certification of expertise, and with the clinical trial process is preferred.
Menlo Park, CA