Irvine, California

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.

JOB DESCRIPTION

 

JOB GOAL:

  • The Clinical Study/Trial Manager is responsible for design, planning, development, and monitoring of clinical research projects.

 

RESPONSIBILITIES:

  • 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.

 

QUALIFICATIONS: 

  • 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
  • Knowledge of ophthalmology is strongly preferred
  • Medical Device industry experience is strongly preferred
  • 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

 

#ACRP



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]]

Irvine, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

Similar jobs