JenaValve Technology, Inc. · 22 hours ago
Manager, Clinical Affairs (Case Review Board)
Irvine, CA
Full-time
Onsite
Mid, Senior Level
5+ years expJenaValve Technology, Inc. is seeking a Manager for Clinical Affairs (Case Review Board) who will report to the Director of Clinical Affairs. This role involves case planning for global clinical trials and collaboration with various stakeholders to enhance the CRB process.
Health CareManufacturingMedical Device
Responsibilities
Drive scheduling and executing CRB meetings with committee members and site-level health care providers across all clinical trials
Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites
Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency
Preparation and review of presentation materials for CRB meetings for all clinical trials with site clinical research coordinators, implanters, and field clinical specialists
Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases
Develop and maintain the CRB charters as needed
Manage and troubleshoot imaging upload and transfer workflow
Partner with clinical sites and core lab(s) to manage and improve subject screening workflow from initial submission to final approval of inclusion for treatment
Development, review, optimization, and implementation of standard operating procedures related to case review board workstream
Serve as the primary point of contact and subject matter expert for patient screening process during study start-up
Maintain and optimize case/subject logs, tracking tools, and regular progress reporting
Maintain, track, and update existing proctor agreements and partner with the contracting team on any new contracts required for expanded trials
Manage and maintain relevant electronic data management platform activities related to clinical trial enrollment
Mentor and provide leadership to junior Clinical Affairs team members through individual development plans and department milestones
Other duties as assigned
Qualification
Required
5+ years of relevant professional experience in clinical operations, site management, case planning, patient screening, etc. is required (preferred in medical devices)
Strong background in Microsoft Office Suite, especially PowerPoint and Excel
Experience facilitating Zoom or Microsoft Teams meetings
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to lead a team and work in a team environment
Experience in line management and developing direct reports is strongly recommended
Working knowledge of clinical study execution and patient screen / case planning
Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Regulations 2017/745, ISO 14155 and ICH Guidelines
Experience in developing and improving processes
Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment
Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work
Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally
Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure
Ability to work pacific standard time hours
Preferred
Advanced degree in a biological science / pharmacy/ nursing desired
Company
JenaValve Technology, Inc.
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).
51-200 employees
H1B Sponsorship
JenaValve Technology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (3)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$341.57MKey Investors
Bain Capital Life SciencesRMMFraunhofer Venture
2024-07-24Acquired
2022-08-31Series C· $100M
2022-01-04Series Unknown· $8M
Leadership Team
John Kilcoyne
CEO
Kari-Lyn Moore
Chief Financial Officer
Recent News
2026-01-11
2026-01-11
Company data provided by crunchbase