Clinical Trial Manager - Ophthalmology Medical Device
Kelly Science & Clinical
Location: Irvine, California
Internal Number: US1593DW_BH3658795
Kelly is currently seeking a Clinical Trial Manager for a long-term engagement with one of our Global Medical Device clients in the Ophthalmology area. This position will be able to work remotely from home office. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Clinical Study/Trial Manager is responsible for design, planning, development, and monitoring of clinical research projects.
Reviews and interprets research results, evaluates the safety and medical usefulness of device candidates
Designs, plans, develops, and monitors clinical research projects which include development of case report forms, informed consent, study device projections, overall project management and communication
Oversees documentation needed for data collection, analysis, reviews and maintains correct standard operations, procedures, and protocol
Validates and/or redirects research based on documented results
Interprets results of investigations in preparing for device application to the appropriate governmental body
Monitors process against clinical research guidelines and safety procedures. Maintains expertise and understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies, and process
Evaluates results that are necessary to determine the safety, efficacy, and medical usefulness of device candidates. Communicates and reports detailed outcomes and results of research findings to relevant groups
Handles project budgets and projections
Reviews and monitors relevant registration, submissions, and reports
Assists in mentoring of colleagues
Partners with clinical research and other departments
Presents research results at meetings, including investigator meetings and company sponsored events
Adheres to environmental policy, procedures, and supports department environmental objectives
Lead project teams, providing input to study design, risk analysis and clinical consultation relative to therapeutic area
Provide leadership to study team
Train site personnel to ensure compliance with study requirements
Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
Minimum education required for competent performance:
Bachelor’s degree required
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
Minimum of 6+ years of clinical research experience with independent field monitoring experience is required
Report into work at JNJ campus as needed is required
Knowledge of ophthalmology is preferred
Medical Device industry experience is helpful
Strong knowledge of GCP, specifically as it applies to investigative site conduct of clinical trials, is required
Ability to successfully balance multiple priorities and adapt quickly to changing priorities
Ability to problem-solve is required
Effective communication via written, verbal and listening skills, with ability to effectively deliver training and educational presentations
Proficiency using MS Word, Excel and PowerPoint is required
Ability to travel up to 15% approximately domestic or international is required
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