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J&J Family of Companies Specialist 4 Clinical Data in Santa Ana, California

Johnson & Johnson Surgical Vision Inc. is recruiting for a Specialist 4 Clinical Data located in Santa Ana, CA.

Johnson & Johnson Surgical Vision designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.

The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.

Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific, and Europe/Middle East/Africa regions. Research, innovation, and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry. The Specialist 4 Clinical Data serves as Data Management's main point of contact for assigned studies, and acts as the data management representative on project teams. He/she is responsible for the initiation and approval of the building, testing and validation of all clinical databases, subsequent changes in databases and data validation activities. The Specialist 4 Clinical Data also manages coordination of the data management project team to ensure that tasks are performed according to Good Clinical Practices(GCP), policies and procedures.

Responsibilities:

• Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the creation of Case Report Forms (CRFs) and prepare or review/contribute to operations manuals

• Organize / chair data management meetings with study project teams

• Create the study specific Data Management Plan

• Perform Clinical Database Hard-lock activities

• Support and assist Clinical Operations and Clinical Sciences staff with all other data management functions

• Perform other related duties as assigned by management

Qualifications

• Minimum of a Bachelor’s degree is required. Bachelor’s in Healthcare or Computer Science is preferred

• Minimum 6+ years experience in Clinical Data Management is required. Medical Device experience is preferred

• Experience with IBM merge/clinical and metadata RAVE is required

• Experience in Project Management principles is required

• Ability to travel up to 10% is required

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-California-Santa Ana-1700 E Saint Andrew Place

Organization

Johnson & Johnson Surgical Vision, Inc (6234)

Job Function

R&D

Requisition ID

2105897958W

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