Cerevasc Welcomes New Clinical Trials Manager
CereVasc is a medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. The Company’s first product, the eShunt™ System, has been developed to treat hydrocephalus, a potentially life-threatening disease also known as “water on the brain.” The eShunt System has the potential to disrupt a 60-year-old standard of care that is fraught with high failure and complication rates that typically result in patients requiring multiple revision surgeries over the span of their treatment.
Developed by two world-renowned neurosurgeons at Tufts Medical Center, the eShunt System is delivered endovascularly and avoids the need for invasive surgery, extended hospitalization, and post-procedure pain management typically associated with the current surgical treatment of hydrocephalus by using conventional shunt devices.
The eShunt System will address a $5 billion market opportunity with a novel alternative to conventional treatments, and has the potential of positively impacting the lives of more than 400k hydrocephalus patients in the US and EU. Conventional treatment possesses a failure rate exceeding 40% by the 2nd year after shunt placement, with each failure requiring patients to undergo additional surgeries.
CereVasc is currently active in first-in-human clinical trials of the eShunt System and soon to be subsequent U.S. clinical studies, and needs a Clinical Trials Manager to support in managing the execution of its clinical trials.
About the Position
Reporting to the VP of Clinical Development, the Clinical Trials Manager (CTM) directs and oversees clinical activities for new and ongoing clinical trials. The CTM performs study start-up and execution activities in a timely manner and in compliance with local and applicable country specific regulatory requirements. The CTM must have excellent written and effective verbal communication skills, proficient in project management, able to work in a fast-paced environment, and comfortable interacting with consultants and contractors.
Responsibilities
- Support all aspects of clinical development and trial management to support company objectives.
- Establishing and ensuring execution of clinical trials in accordance with applicable regulations including: writing clinical trial documentation; preparing submission files to relevant parties; site identification, qualification, initiation and follow-up with study sites as needed; oversee monitoring of clinical trials; contributing to clinical study reports; closure of clinical studies.
- Support completion of site clinical study contracts and budgets and tracking of associated study costs.
- Collaborating with other departments to ensure relevant review and representation of clinical data.
- Management of individuals, including consultants and contractors, establishing and ensuring follow-up of clinical studies in accordance with applicable regulations
- Providing trainings dedicated to good clinical practices as needed with sites and other study personnel.
- Ensuring continuity of clinical investigation vigilance when required.
- Coordinates clinical activities with CROs, Notified Body, FDA, IRBs, ECs and outside consultants to ensure that all clinical requirements are satisfied.
Preferred Qualifications & Experience
- Undergraduate degree or its international equivalent in a clinical, science, or health-related field from an accredited institution preferred, a liscenced health-care professional (i.e. registered nurse); or equivalent work experience.
- 7+ years of clinical research experience preferred, including at least 4 years’ experience in clinical trial management preferred.
- Read, write and speak fluent English.
- Experience in managing complex trials or global trials preferred.
- Excellent knowledge of Good Clinical Practices and associated guidance.
- Excellent written and computer skills.
Work Environment
Remote, ability to travel periodically as needed.
Interested in learning more? 180one is assisting CereVasc in this search. If interested in learning more about the opportunity, please contact Lisa Heffernan at 180one (971.256.3076 / Lisa@180one.com)

