J&J Family of Companies Clinical Research Manager in Irvine, California
Clinical Research Manager
Operating on behalf of the Cerenovus platform, this clinical research manager will be responsible for supporting the development of evidence generation / dissemination strategies, execution of real-world evidence studies, and partnering with cross-functional teams to ensure clinical activies are aligned with upstream R&D and new product development activities as well downstream marketing and product positioning objectives.
CERENOVUS is a global neurovascular company that offers a broad portfolio of devices including aneurysm coils, vascular reconstruction devices, stent retrievers and other technologies used in the endovascular treatment of cerebral aneurysms and stroke, minimally invasive solutions for stroke prevention and management, and the treatment of cerebral arteriovenous malformations. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within J&J medical devices.
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain ( ischemic stroke (http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/IschemicClots/Ischemic-Strokes-Clots_UCM_310939_Article.jsp) ) or by a blood vessel rupturing and preventing blood flow to the brain ( hemorrhagic stroke (http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/HemorrhagicBleeds/Hemorrhagic-Strokes-Bleeds_UCM_310940_Article.jsp) ). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
Develop and deliver appropriate evidence generation / dissemination (EGS/EDS) to support new product development (NPD) / life cycle management (LCM) for assigned products. Ensure input and strong alignment from key stakeholders and business leaders in the EGS/EDS activities and deliverables
Analyze and interpret study results that translate to downstream marketing claims and value proposition; review data and provide input on clinical study reports, clinical evidence reports, abstracts, manuscripts, and other publications
Summarize key product evidence from published literature and provide updates to internal stakeholders on a regular basis
Develop a strong understanding of the neurovascular product portfolio and pipeline
Provide leadership on assigned clinical projects.
Responsible for delivery of assigned clinical programs, through effective partnership with the cross functional partners, including but not limited to Biostats & Data Management, Medical Affairs, Global Strategic Marketing, Regulatory Affairs, HEMA, and R&D, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOPs)
Develop strong collaborative relationships with Study personnel/investigators and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
Support the Clinical Research team in publication planning and development and manages Investigator Initiated Study publications tracking.
Develop high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs.
Support the implementation of new clinical systems/processes.
Functional and Technical Competencies :
Experience with medical writing and systematic literature review highly preferred
Thorough understanding of clinical research and processes (GCPs) along with a good understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
Proven track record in delivering clinical programs on time, within budget and in compliance to SOPs and regulations
Ability to lead teams to deliver critical milestones
Ability to collaborate across different functional to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives
Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
Leadership requirement – ability to influence, shape and lead without direct reporting authority
Experience in effective management of project budget processes
Good written and oral communication skills
Possess advanced understanding and maintain current knowledge of industry standards on clinical research and publication development.
A Bachelor’s degree in Biological Science or related discipline, with a minimum of 6 years related scientific / technical experience, including leadership / management role within Clinical Research. With a PhD or Masters, these requirements would be a minimum of 4 years related scientific / technical experience, respectively.
Previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background a plus.
Experience managing projects a plus.
Medical device experience highly preferred
United States-California-Irvine-33 Technology Drive
Medical Device Business Services, Inc (6029)
J&J Family of Companies
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