Johnson & Johnson Careers

Clinical Study Manager – Surgical Vision Instrumentation

Milpitas, California
Clinical Research non-MD


Job Description

Requisition ID: 1924180618

Clinical Study Manager – Surgical Vision Instrumentation
 
Johnson & Johnson Vision Surgical, part of the Johnson & Johnson Family of Companies, is currently recruiting for a Clinical Study Manager – Surgical Vision Instrumentation, to be located in Milpitas, Ca.
 
Johnson & Johnson Vision Surgical (“JJVS”) is focused on the discovery, development and commercialization of medical devices for cataract and refractive surgery. As a global cataract leader, JJVS provides intraocular lenses (both monofocal reimbursed and premium IOLs) that are specially designed to provide optimized visual outcomes, phacoemulsification and femtosecond laser equipment to safely and efficiently remove cataracts and a full offering of surgical adjuncts, including sterile viscosurgical devices/solutions. 
 
JJVS is the global market leader in the presbyopia correcting IOL marketplace and holds strong #2 positions in all other cataract surgery markets in which it competes. JJVS is also the global market leader in laser refractive surgery and provides excimer and femtosecond lasers and advanced diagnostic devices for corneal refractive surgery. JJVS provides its products in more than 150 countries (more than 60 with a direct sales presence) worldwide.
 
The Clinical Study Manager will be responsible for overseeing the conduct of clinical trials in compliance with relevant regulations, guidance's, directives, and standards. S/he will also ensure P.O.s and invoices are accurate and timely in accordance with contracts and budgets.
 
The Clinical Study Manager will:
 
· Plan and manage all aspects of the conduct of Clinical Research such as developing, planning, and oversight of clinical studies.
· Comply with department, company and regulatory standards and procedures.
· Account for assigned study timelines, resourcing, and budget management.
· Partner with functional groups and/or vendors to ensure execution of clinical trials are done with efficiency and effectiveness, and are compliant to EHS and all applicable JJVS procedures.
· Ensure that clinical trials are conducted in a manner that meets all applicable Regulations and Guidelines.
· Develop request for proposals for clinical sites and CROs and other vendors as required. Support the development of Master Services Agreements, Clinical Research Agreements, Scope of Work and Change Orders.
· Interface with Research and Development, Regulatory Affairs, Medical Affairs, Office of Project Management, etc. to ensure that company requirements for clinical execution are met.
· Perform other related duties as assigned by management.
Qualifications
· Bachelor of Science or equivalent degree is required.
· 5+ years of experience in Clinical Operations in a medical device/pharmaceutical regulated industry, with previous clinical experience required.
· 2+ years of experience as a Clinical Research Associate preferred.
· Complete understanding and application of principles, concepts and practices of Good Clinical Practice (GCP) is required.
· Broad understanding of surgical instrumentation used in Ophthalmology is preferred.
· Strong communication, organizational, and interpersonal skills are required.
· Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Regulatory, Project Management, etc.) is preferred.
· Flexibility to provide innovative approaches to support clinical research is preferred
Primary Location
United States-California-Milpitas
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Clinical Research non-MD
Requisition ID
1924180618