LOCATION
U.S. - Remote
TECHNOLOGY
Neurovascular Catheters
COMPANY HQ
Galway, Ireland
COMPANY SIZE
11-50 Employees
POSITIONOVERVIEW
Perfuze has developed multiple neurovascular catheters receiving 510(k) and CE Mark approval for its zipline access catheter, and is in an active IDE study for its super-bore aspiration catheter. Perfuze closed its Series A investment round of €22.5M in 2022 bringing total capital raised to ~€35M and is being clinically tested in a 180-patient, 20-site, U.S. pivotal trial in pursuit of FDA approval for the thrombectomy catheter. Perfuze is hiring its Lead CRA/Clinical Trial Manager.
- Technology Video: Click here
- News Article: 510(k) Approval and First U.S. Patient
We have partnered with Wayne Allen, CEO, and Veronica Lewis, Director of Clinical Affairs, to hire our Lead CRA/Clinical Trial Manager. This position will be responsible for clinical site startup and management for our IDE study while supporting cases in the Core Labs to answer technical details about the study protocol. This position will support site initiation visits while managing our CRO across 12-15 clinical sites for our 100+ patient study in the U.S.
POSITIONDETAILS
- Lead the internal and external study teams in the successful execution of assigned studies
- Meet timelines and deliverables while ensuring compliance with GCP, relevant SOP’s and regulatory requirements
- Develop and execute detailed project plans including site, vendor, and budget management
- Plan and lead investigator and study meetings as needed
- Review, and approve study protocols and supporting documents including site contracts
- Drive study start up, patient recruitment, clinical monitoring, and study closeout
- Plan and coordinate project/protocol specific and therapeutic area training as needed
- Travel to sites and/or vendors to assess project progress and compliance
- Ensure study risks are identified, managed, and mitigation strategies are implemented
- Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget
- Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents
- Develop clinical study reports for submission to regulatory authorities
- Oversee and review deliverables produced by study team members to ensure quality and compliance
- Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
- Create and maintain clinical study documents as part of the trial master file (TMF)
- Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants
- Conduct on-site clinical monitoring activities as needed
- Lead and actively participate in various cross functional team meetings
- Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded
- Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)
- Relevant Technical or Bachelor’s degree required
- Class III MedTech IDE experience required
- Experience managing a CRO
- Familiarity with principles of clinical research design
- Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner with limited direction
- Ability to establish and foster effective communication and relationships with investigators, vendors, and internal colleagues that support and advance trial team goals and objectives
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Self-directed, resourceful, and able to get work done without significant input.
- Good organizational skills, attentive to details, and able to multitask.
- Strong problem-solving skills and ability to deal with changing priorities.
- Strong written, verbal, and presentation skills.
COMPANYOVERVIEW
Perfuze was founded in 2018 by Wayne Allen and Liam Mullins. Perfuze is located within Galway City in the West of Ireland and is a medical device company developing next-generation “super-bore” catheter technology to treat ischemic stroke. The founders have over 30 years combined MedTech experience within start-up and large corporations and are committed to bringing devices to market that have the potential to transform the treatment of acute ischemic stroke.
We develop devices intended to increase the rate of the First Pass Effect underpinned by:
- Complete clot ingestion
- Improved ease of use
- No loss of access
- Reduced requirement to bail-out to alternative technologies
- Reduced need to combine technologies or use hybrid techniques
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Company Overview
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Clinical Project Manager
Remote (US)
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