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Clinical Trial Manager

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About the role

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Clinical Trial Manager
Seoul, Korea
 
ICON plc, a leading global Contract Research Organisation (NASDAQ listed) employing 13,500 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  www.iconplc.com
 
SUMMARY
Working as a Clinical Trial Manager includes many different responsibilities. The main part of this is that you will be leading programs to develop and trial new drugs.
Your duties will include finishing research programs in good time and on budget, all the while complying with regulatory and ethical requirements. Having a bachelor’s degree in a science or medical area will be a minimum requirement and ideally you’ll have a master’s degree that focuses on clinical research. Key parts of the job include project management, team management, the ability to communicate well, an understanding of compliance as well as the confidence to obtain funding. Communication with your team, stakeholders and senior members of the company is crucial so this is definitely a role for those who have good interpersonal skills.
 
JOB FUNCTIONS/RESPONSIBILITIES
  • Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients
  • Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects
  • Contribute to the development and maintenance of cross functional project management plans
  • Responsible for risk mitigation strategies, associated action plans and issue resolution
  • Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff
  • Provide direction and support to the Clinical Operations study team
  • Manage Clinical Operations aspects of projects in accordance with the contract including communicate any changes in Clinical Operations scope to the Project Manager and collaborate with Business Development to ensure timely completion of change orders
  • Track Clinical Operations project deliverables using appropriate tools
  • Effectively monitor and report on progress of the Clinical Operations aspects of projects to all stakeholders
  • Implement QC activities as necessary and monitor required quality metrics
  • Participate in business development activities, as appropriate including bid defense and proposal activities
  • Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff
 
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
  • Experience in a Lead CRA/Project Lead or equivalent role and 7+ years of total experience in the clinical research field.
  • Successful industry experience, of clinical trial management and a proven understanding of the clinical operations aspects of projects and how they impact/interact with other functions
  • Thorough knowledge of ICH GCP and relevant regulations and a basic knowledge of the drug development and clinical trials process.
  • Proven leadership and ability to make complex decisions with minimum management oversight and work independently within the role
  • Experience in managing sites with in depth knowledge in local requirements and regulations in Philippines
  • Knowledge of Clinical Operations processes and tools
  • University/Bachelor’s Degree, or local equivalent, in medicine, science or equivalent degree/ experience
  • Fluent in written and spoken English.
  • Computer literate.
  • Due to the nature of this position it may be required for the employee to travel both domestically and internationally.
 
Benefits of Working in ICON
ICON enjoys a proven reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
 
Other than working with a phenomenal team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com    
 
 
 
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