Clinical Study Manager
Posted Date: Sep. 04, 2022
CathWorks, based in Israel and Irvine, CA, 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 Study Manager at CathWorks, you will be responsible for planning and executing company sponsored global clinical trials for the CathWorks FFRangio® System. It is a hands-on, high impact role with the opportunity to help transform how physicians manage patients with cardiovascular disease. If you have the entrepreneurial drive, demonstrated ability to collaborate with a variety of stakeholders in a fast-paced, “start- up” environment, CathWorks is the place for you.
- Plan, initiate and execute clinical studies with operational excellence
- Plan and implement IRB submissions, site qualification, investigator qualification, site initiation, monitoring and close out activities in compliance with GCP and all applicable federal regulations.
- Be accountable for effective management of budgets, timelines and resources for clinical studies and implementation of appropriate standards and processes to ensure clinical study quality
- Be responsible for effective training and management of interactions with study team, study sites and vendors for clinical studies
- Manage and lead the day-to-day operations of studies to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Provide accurate and up-to-date study information and provide regular updates of study progression
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data
- Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
- BA/BS degree with at least seven years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 5 years clinical trial experience
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Requires proven project management skills and study leadership ability.
- Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
- Up to 30% travel, sometimes over the weekend
CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines AI and computational science to obtain physiologic information from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with a quick and reliable intraprocedural physiologic assessment for the entire coronary tree, making it practical for every patient. For more information on CathWorks, visit cath.works and follow @CathWorks on Twitter and LinkedIn.
Equal Opportunity Employer:
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.