Respicardia, ZOLLMED.com
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.
As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.
Job Type
Hybrid - Enjoy the flexibility of a hybrid model, working in our Minnetonka office 2-3 days per week and remotely the remainder of the time.
Job Summary
This position is responsible for the operational lead for assigned clinical trials, managing daily activities for Clinical Project Teams across single- and multi-center studies both inside and outside of the United States. The Senior Clinical Project Manager collaborates with internal teams, Clinical Research Organizations (CROs), vendors, contractors, and sites to ensure clinical trials are completed based on set goals.
Essential Functions
- Oversee the day-to-day management of the assigned clinical trial(s).
- Lead site selection meetings and participate in the identification, evaluation and selection of investigational sites.
- Lead and document trial-specific meetings: trial team, steering committee, compliance, etc.
- Create and update the trial-specific operational plans including monitoring, safety, risk management, vendor management, etc.
- Work with investigational sites in the United States and Europe.
- Track and trend monitoring visit compliance and monitoring visit findings to ensure compliance with the clinical investigational plan and the monitoring plan.
- Review and approve monitoring reports.
- Train Clinical Affairs team members on the clinical investigational plan, the monitoring plan and other trial-specific plans and manuals.
- Lead development of clinical investigational plans, informed consent documents, clinical trial agreement templates, investigational site budget templates, site qualification and site initiation visit slide decks, clinical trial reports, regulatory reports and/or committee reports as needed.
- Manage Central Institutional Review Board (IRB) for assigned trials.
- Maintain a strong working knowledge of clinical trial systems such as Electronic Data Capture (EDC), electronic Trial Master File (eTMF), etc.
- Oversee investigational device accountability.
- Manage core labs including collaborating with the core labs to develop trial-specific manuals.
- Approve investigational site and vendor invoices for amounts allowed by the governing Standard Operating Procedures (SOP).
- Provide regular updates on the status of trial conduct to the Chief Medical Officer and Director of Clinical Affairs.
Required/Preferred Education and Experience
- Bachelor's Degree in life science, nursing or an equivalent
- Advanced Degree preferred
- 3+ years equivalent experience in medical device industry required
- 5+ years of Clinical Project Management experience required
- Medical device experience with Class III Implantable Medical Devices required
- Field Monitoring experience preferred
Knowledge, Skills and Abilities
- Thorough understanding of ICH GCP guidelines and ability to review and evaluate medical data.
- Strong written, verbal, and interpersonal communication skills.
- Demonstrated capacity to work independently and manage multiple clinical trial assignments.
- Ability to deliver accurate, high-quality work within tight deadlines.
- Proficiency in Microsoft Office (Word, PowerPoint, Excel).
- Skilled in reviewing, interpreting, and ensuring quality control of clinical trial data and documents.
- Ability to ensure accuracy and quality of monitoring activities (site initiation, interim monitoring, and trial closeout visits).
- Compliance with ethical, legal, scientific and regulatory standards.
- Excellent organizational skills, attention to detail, and customer service orientation.
Travel Requirements
- Ability to travel 25% of working hours (regionally, domestically and internationally as needed)
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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