Ref #: 35054
Employment type: Permanent - Full-Time
Location: Seoul, Korea
Posted: 07-Feb-2022
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role: Clinical Trial Manager (CTM) - Sr. CTM
Overview:
The Clinical Trial Manager is responsible for the management of clinical sites being considered and/or participating in clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CDC’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high quality interactions with global clinical trial sites to drive to an unparalled customer experience. The CTM is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends.
Key responsibilities:
1. Clinical Investigator Management
• Accountable for activities required at clinical trial sites and by investigators and site staff participating in trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out
• Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution
• Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
• Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
• Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable
2. Clinical Trial Management
• Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
• Ensure site and country level inspection readiness at all times
• Leverage metrics to inform site/country/regional level decision making
• Work with internal and external teams to remove barriers to trial execution at a site and/or country level
• Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required
• Provide vendor oversight for site monitoring activities at site/country level Business Management and Engagement
• Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in clinical trials.
• Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio
• Perform targeted sites prospecting in alignment with portfolio strategy & priority
• Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
• Serve as an effective communication “bridge” between sites, third party vendors and
• Influence and challenge internal and external factors in order to improve clinical research delivery
Key responsibilities:
• Bachelor’s degree or equivalent in a scientific or health-related field
• Minimum of 3 years’ experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice
•Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
•Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
• Demonstrated strategic agility & broad business acumen
• Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainity
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role: Clinical Trial Manager (CTM) - Sr. CTM
Overview:
The Clinical Trial Manager is responsible for the management of clinical sites being considered and/or participating in clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CDC’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high quality interactions with global clinical trial sites to drive to an unparalled customer experience. The CTM is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends.
Key responsibilities:
1. Clinical Investigator Management
• Accountable for activities required at clinical trial sites and by investigators and site staff participating in trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out
• Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution
• Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience
• Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data
• Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable
2. Clinical Trial Management
• Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks
• Ensure site and country level inspection readiness at all times
• Leverage metrics to inform site/country/regional level decision making
• Work with internal and external teams to remove barriers to trial execution at a site and/or country level
• Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required
• Provide vendor oversight for site monitoring activities at site/country level Business Management and Engagement
• Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in clinical trials.
• Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio
• Perform targeted sites prospecting in alignment with portfolio strategy & priority
• Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel
• Serve as an effective communication “bridge” between sites, third party vendors and
• Influence and challenge internal and external factors in order to improve clinical research delivery
Key responsibilities:
• Bachelor’s degree or equivalent in a scientific or health-related field
• Minimum of 3 years’ experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice
•Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs
•Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed
• Demonstrated strategic agility & broad business acumen
• Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainity
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
#CRAJob