Clinical Project Manager - Newport Beach, United States - Cathworks

Description

CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally.

The CathWorks FFRangio System combines artificial intelligence (AI) and computational science to provide physicians with comprehensive physiologic information, enabling them to make better treatment decisions for their patients with coronary artery disease.

Recently, CathWorks entered into a strategic partnership with Medtronic to market and sell the FFRangio System globally.

Medtronic is the global leader in medical technology and has more than 90,000 employees worldwide in more than 150 countries.

The partnership with Medtronic will expand CathWorks' footprint globally, enabling more patients to benefit from its revolutionary technology that is poised to disrupt the current coronary physiology market.

As the Clinical Project Manager at CathWorks you will play a crucial role in the planning, execution and tracking of global clinical study activities for FFRangio and the ALL-RISE study. If you have the entrepreneurial drive and demonstrated ability to collaborate with a variety of stakeholders in a fast-paced "start
- up" environment, CathWorks is the place for you. This role reports to the Sr. Director, Medical Affairs & Scientific Communications.


Key Responsibilities:

• Develop and manage comprehensive clinical study project plans, including timelines, budgets, and resource allocation.
• Collaborate with crossfunctional teams, including Medical Affairs, R&D, Marketing, Field team, and external partners and vendors to ensure alignment and seamless execution of clinical projects.
• Coordinate the preparation and submission of regulatory documents, including study protocols, investigator brochures, and informed consent forms.
• Support study activities like site selection, initiation, monitoring, and closeout activities to ensure compliance with study protocols and regulatory requirements.
• Monitor clinical study progress, identify risks and issues, and help implement corrective actions as needed to keep projects on track.
• Conduct regular project status meetings and provide timely updates to stakeholders on key milestones, deliverables, and study progress.
• Provide support for administrative tasks such as coordinating site initiation visits (SIV), investigator meetings, drafting newsletters, and following up with field teams and sites to ensure timely completion of studyrelated activities.
• Maintain uptodate knowledge of industry trends, regulatory requirements, and best practices in clinical research and project management.

Qualifications:

• Bachelor's degree in a relevant discipline; advanced degree (e.g., MS) preferred.
• Minimum of 4 years of experience managing clinical projects in the medical device industry.
• Basic understanding of regulatory requirements governing clinical research, including GCP, is desirable.
• Excellent project management skills, including the ability to develop and maintain detailed project plans, timelines, and budgets.
• Effective communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Experience working with AROs, investigational sites, and KOLs to support clinical trial activities, preferred.
• Strong analytical and problemsolving skills, with the ability to anticipate and mitigate risks to project timelines and budgets.
• Prior experience with medical device clinical trials, including knowledge of relevant therapeutic areas and study designs, is highly desirable.
• Up to 15% travel may be required.

About CathWorks
CathWorks, Inc. is an Equal Opportunity Employer.

This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law.

Hiring, transferring and promotion practices are performed without regard to the above-listed items.

Unless stated otherwise, all positions posted for CathWorks are not intended for or open to third party recruiters/agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.