Sr Study Start Up Associate
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
ICON Clinical Research is Whole Owned Foreign Company which founded in 1990 in Ireland. We expanded our business from 1996 in APAC region.
Currently we are hiring a Senior Study Start Up Associate role in Taiwan.
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU you will be responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)
Role Summary
Serving as a primary contact for investigators and research coordinators, you will perform feasibility, site identification, site contract negotiation and other assigned study startup activities. This will include the preparation, review and approval of country related ethics/regulatory submission packages and site level critical documents for Investigational Product (IP) release. Some travel is anticipated, to attend Kick-Off, Investigator and/or study team meetings..
Role Responsibility
• Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned
• Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams.
• Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
• Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)
• Review and translate Drug labels
• Perform independent quality review of submission packages.
• Responsible for the translation and co-ordination of translations for documents required for submission.
• Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system
• Copy and route incoming correspondence, internal documentation, etc., as appropriate
• Responsible for the timely follow-up for queries made by EC/CA
• Responsible for the collection of critical documents required for IP Release
• Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA)and Ethics Committee (EC) submission information, and similar information for other related.
• Develop and maintain effective relationships with local, regional and country authorities
• Comply with all department requirements regarding information provision and status updating and reporting
• Travel(approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defences, Kick-Off, Investigator or study team meetings.
Experience and Qualification
• A minimum of 1 years of experience in Study Start-up area
• Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)
• Good organizational skills and the ability to manage multiple tasks
• An excellent level and proven experience high standards of attention to detail
• Good written and verbal communication skills. Proficient in English and language required for country assignments
• Ability to liaise with colleagues from Study Start Up, other departments and clients, if required
• Strong project management skills
• Highly developed problem solving skills
• Strong people management and effective communication skills
• Customer service focused
• Solution-focused
• Bachelor’s Degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline
Comparing with our competitor and pharmaceutical companies, we provide more flexible and reasonable working platform for coach and educate the new comer to be a professional person to concentrate on relevant industry. ICON also provides the good package and benefit to adapt the marketing development.
We more like a whole family with kind-heart and warm carefulness which you can balance your life and work here.
If you want to review more please visit our company website: www.iconplc.com or careers.iconplc.com. Or you can send the email to me directly: Jennifer.kim@iconplc.com
Welcome to join ICON.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Clinical Monitoring
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-110249
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Regional United States (PRA)
Department
Full Service - Symphony Health
Location
Multiple US Locations
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Consulting
Project/ Program Management
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR115776
Expiry date
01/01/0001
Author
Lindsey EltzrothAuthor
Lindsey EltzrothSalary
Location
Mexico, Mexico City
Department
Clinical Monitoring
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Reference
JR118632
Expiry date
01/01/0001
Author
Justin HovisAuthor
Justin HovisSalary
Location
Regional Mexico (PRA)
Department
Full Service - Development & Commercialisation Solutions
Location
Brazil
Chile
Mexico
Peru
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
Location: Insurgentes SurHybrid Model - 3 days at the office peer week.ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance cli
Reference
JR115000
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
United Kingdom
Department
Clinical Operations Roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
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
2024-109927
Expiry date
01/01/0001
Author
Rajvir SamraAuthor
Rajvir SamraSalary
Location
US, Piedmont, NC
Location
Piedmont
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Research Site Services
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR118298
Expiry date
01/01/0001
Author
Sasha BrownAuthor
Sasha Brown