Study Start Up Associate I
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings
- Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned
- Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- This includes, but it is not limited to:
- ethics/regulatory/other relevant authority approvals for clinical trials
- ethics/regulatory/other relevant authority approvals for trial amendments
- ethics/regulatory/other relevant authority study notifications
- authorizations for import/export of investigational products, clinical supplies and biological samples
- approvals from the national authorities for data protection
- Review and translate Drug Labels
- Advise Sponsor on knowledge content for development of Drug Labels
- Perform independent quality review of submission package
- 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 organizations, for the assigned countries and update relevant ICON information system
- Responsible for the translation and co-ordination of translations for documents required for submission
- Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system
- Copy and route incoming correspondence, internal documentation, etc., as appropriate
- Responsible for the collection of critical documents required for IP Release
- Attend study team meetings as required (maybe discretionary), including Kick-Off Meetings which are mandatory
- Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate
- To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs
- Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation
- Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
- Previous relevant experience
- Experience and/or understanding of clinical study start up requirements and activities
- An excellent level and proven experience high standards of attention to detail
- Excellent written and spoken English
- Competent computer skills
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license
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
India, Chennai
Department
Clinical Trial Management
Location
Bangalore
Chennai
Bengaluru
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document 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
JR117226
Expiry date
01/01/0001
Author
Gowri Shankar Nalla PerumalAuthor
Gowri Shankar Nalla PerumalSalary
Location
Taiwan, Taipei
Department
Clinical Monitoring
Real World Solutions
Location
Taipei
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
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
JR118485
Expiry date
01/01/0001
Author
Candice WangAuthor
Candice WangSalary
Location
New Zealand, Auckland
Location
Auckland
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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 It
Reference
JR114295
Expiry date
01/01/0001
Author
Alvin ParkAuthor
Alvin ParkSalary
Location
China, Shanghai
Department
Clinical Monitoring
Location
Shanghai
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Job Advert PostingAt 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’
Reference
JR113644
Expiry date
01/01/0001
Author
Jessica ZhongAuthor
Jessica ZhongSalary
Location
New Zealand, Auckland
Location
Sydney
Auckland
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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
JR114551
Expiry date
01/01/0001
Author
Alvin ParkAuthor
Alvin ParkSalary
Location
India, Bangalore
Department
Full Service - Development & Commercialisation Solutions
Location
Bangalore
Chennai
Trivandrum
Bengaluru
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial 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
JR118327
Expiry date
01/01/0001
Author
Ekta Chandra SrivastavaAuthor
Ekta Chandra Srivastava