Study Start Up Associate I
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
Study Start Up Associate I, II
Seoul, Korea
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)
Overview of the role
- 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 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
- ethics/regulatory/other relevant authority approvals for clinical trials
- 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 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
Role Requirements
- Bachelor’s Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
- At least 1 year of previous relevant experience in Study Start Up area
- Experience and/or understanding of clinical study start up requirements and activities
- An excellent level and proven experience high standards of attention to detail
- Good command of 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
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. 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.
What’s Next
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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
Mexico, Mexico City
Department
Drug Safety & Pharmacovigilence
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Clinical Supplies
Job Type
Permanent
Description
Clinical Supplies Project ManagerICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced s
Reference
JR116640
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth DaviesSalary
Location
Ireland, Europe, United Kingdom, South Africa, Poland, Bulgaria, Spain, Germany, Netherlands, Romania, Czech Republic, Slovakia
Department
Biometrics Roles
Location
Any EMEA Location
Bulgaria
Czech Republic
Germany
Ireland
Netherlands
Poland
Romania
South Africa
Spain
UK
Slovakia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Statistics
Job Type
Permanent
Description
As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2023-104906
Expiry date
01/01/0001
Salary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2023-103323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Early Phase Services
Job Type
Permanent
Description
Senior Clinical Associate - Buenos Aires, Argentina ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research prov
Reference
JR118995
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth Davies