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Clinical Research Project Manager (842-547)

Clinical Research Project Manager (842-547)

Job Description

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.

Job Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Educations and/or Experience:

• Bachelor of Science degree
• Advanced degree in a scientific discipline or at least 3 years equivalent experience in medical device industry
• Clinical Project Lead/Clinical Project Management experience , preferred
• Field Monitoring experience, preferred
• Well-versed in medical terminology and ICH/GCP guidelines
• Knowledge of field-based monitoring procedures
• Knowledge of legal and regulatory landscape concerning clinical research
• Professional use of the English language, both written and oral
• Excellent organizational skills with attention to detail
• Demonstrated proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out)
• Ability to work with minimal supervision once given instructions

Follow your aspirations to ZOLL Medical Corporation for diverse opportunities, competitive salaries, great benefits and a 401(k) retirement savings plan, all with a company providing the growth and strength to build your future. For immediate consideration, please forward your resume, including cover letter with salary requirements.


ZOLL is an Equal Opportunity Employer

Job Snapshot

Employment Type Full-Time
Job Type Health Care
Education 4 Year Degree
Experience At least 3 year(s)
Manages Others Not Specified
Industry Manufacturing
Required Travel Up to 25%
Job ID 842
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Clinical Research Project Manager (842-547)

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