Clinical Trial Manager
- South Korea
- ICON Strategic Solutions
- Clinical Trial Management
TA Business Partner
- Icon Strategic Solutions
About the role
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.
What you will be doing:
- Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
- Lead Local Study Team(s) consisting of monitors and study administrator(s).
- Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with company Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
- Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
- Perform any required co-monitoring & QC visits with study monitor(s)
- Proactively identify and facilitate resolution of complex study problems and issues.
- Organise regular Local Study Team meetings on an agenda driven basis.
- Actively work towards achieving good personal relationships with all Local Study Team members.
- Report study progress/update to the SMO Study Leader/Team.
- Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
- Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
- Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
- Plan and lead national Investigator meetings, in line with local codes
- Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
- Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
- Ensure timely preparation of country SMA, fSMA and Master CSA.
- Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
- Ensure local Serious Adverse Event (SAE) reconciliation takes place.
- Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
- Ensure timely submission of proper application/documents to EC/IRB.
- Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
- Set up and maintain the study in IMPACT at study country level.
- Ensure accurate payments related to the study are performed.
- Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and company Procedural Documents.
- Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
- Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
- Provide input to process development and improvement.
- Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
- Update SMM Director/CRM about the performance of the monitors/CRAs.
- Ensure that study activities at country level comply with local policies & code of conduct.
#LI-remote
#LI-SO1
You are:
Functional Capabilities
- Excellent knowledge of international guidelines (ICH/GCP) and relevant local regulations.
- Good understanding of the Drug Development Process.
- Excellent understanding of the Clinical Study Process (Monitoring, Study drug handling process, Data management process).
Essential Qualification
- Bachelor’s degree
- +1 year Clinical Trial Management experience in global CROM/Pharam
- +7 yrs moniotring experience
Desired skills or requirements
- Excellent knowledge of spoken and written English.
- Good ability to learn and to adapt to work with IT systems.
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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Career ProgressionContent type
BlogsPublish date
02/17/2023
Summary
Clinical Trial Managers and Clinical Project Managers are an integral part of the clinical market. Each role is essential in ensuring that clinical trials are well run and completed to a high stan
Similar jobs at ICON
Salary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115068
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-115079
Expiry date
01/01/0001
Salary
Location
Budapest
Department
Clinical Trial Management
Location
Budapest
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
To lead Local Study Team at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents,international gu
Reference
2024-115059
Expiry date
01/01/0001
Author
Orsolya BerkeAuthor
Orsolya BerkeSalary
Location
Slovakia
Department
Clinical Trial Management
Location
Slovakia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Clnical Trial Manager provides local manage
Reference
2024-114871
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Tbilisi
Department
Clinical Trial Management
Location
Tbilisi
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-115004
Expiry date
01/01/0001
Author
Michal CzyrekAuthor
Michal CzyrekSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Senior Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114558
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon Pupek