ZOLL LifeVest, a Pittsburgh-based subsidiary of ZOLL Medical Corporation, develops, manufactures and markets a wearable defibrillator for persons with Sudden Cardiac Arrest (SCA) risk in the United States and Europe. The LifeVest is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess their long-term arrhythmic risk and make appropriate plans. The LifeVest is lightweight and easy to wear, allowing patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest is covered by most health plans in the United States, including commercial, state, and federal plans.
Clinical Research Manager is responsible for the execution of clinical studies and overseeing the day-to-day operations of multiple clinical trials, interfacing with clinical sites, and interacting with other internal functional teams.
Essential Duties and Responsibilities:
- Manage multiple trials to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
- Assist with site selection and site qualification visits.
- Acts as main contact for study site and provide answers to study and device-related questions.
- Communicate regularly with Investigator sites and vendors to ensure smooth study set up and maintain exceptional study conduct, review site performance, and identify and be aware of site/study issues.
- Conduct motivational visits, as well as, develop materials and initiatives to support patient recruitment and retention with each site.
- Proactively communicate the status of ongoing projects, issues, and risks that may affect the clinical trial and project schedule with internal team.
- Assist with monitoring procedures including routine monitor and close-out visits, audit preparation, final study report, and completion of financial obligations.
- Assist with the development and facilitation of clinical documents including informed consent forms, case report forms, study manuals, Standard Operating Procedures, and other clinical materials to ensure compliance with regulatory, IRB, and company policies.
- Facilitate/prepare technical reports, summaries, and quantitative analyses.
- Some travel required
- Performs other duties as assigned by Management.