JUMP TO CONTENT

Study Start Up Associate II

JR069055

About the role

This vacancy has now expired. Please click here to view live vacancies.

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 EC & CA submissions, site contract negotiations 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 site contract negotiations, 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 Drug labels

* Perform independent quality review of submission packages.

* Responsible for the translation and co-ordination of translations for documents required for submissions.

* 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 2 years of hands on experience in Clinical 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 local 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

List #1

Day in the life

Headshot of female
From Lab Bench to Program Leadership: Sinéad McKeon's Career at ICON

Teaser label

Our People

Content type

Blogs

Publish date

02/05/2026

Summary

Building expertise through diverse roles and continuous learning Sinéad McKeon's career at ICON demonstrates how scientific training can evolve into strategic leadership. Now a Senior Manager in Lab

Teaser label

Discover how a career can evolve from hands on lab work to program management in this interview with Sinéad McKeon.

Read more
Headshot image of male
Shaping the Future of Patient Safety: A Conversation with Hassan Aljobori

Teaser label

Our People

Content type

Blogs

Publish date

02/05/2026

Summary

Shaping the Future of Patient Safety At ICON, patient safety is the foundation of everything we do. Hassan Aljobori, Director of Pharmacovigilance, shares his journey through nine years of growth

Teaser label

Hassan shares his career journey, advice for building a career in pharmacovigilance, and what sets ICON apart as an employer.

Read more
Izabella's Journey Back to ICON

Teaser label

Our People

Content type

Blogs

Publish date

01/26/2026

Summary

Sometimes the best way to recognise what you have is to experience life without it. For Izabella Grimaldi, a Clinical Research Associate II based in Brazil, that realisation came after seven months wo

Teaser label

Izabella shares what makes our culture, leadership, and opportunities worth coming back for.

Read more
View all

Similar jobs at ICON

Site Activation Lead - Sponsor dedicated

Salary

Location

Israel, Tel Aviv

Location

Tel Aviv

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Site Activation

Job Type

Permanent

Description

We are currently seeking a Site Activation Lead to join our diverse and dynamic FSP team. As a Site Activation Lead at ICON, you will advance clinical trial start-up activities by understanding client

Reference

JR144533

Expiry date

01/01/0001

Salome Kankia

Author

Salome Kankia
Read more Shortlist Save this role
Regulatory Submissions Manager (EU CTR)

Salary

Location

France, Paris

Location

Paris

Barcelona

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development

Reference

JR144301

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Regulatory Submissions Manager (EU CTR)- Turkiye

Salary

Location

Turkey, Ankara

Location

Ankara

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development

Reference

JR143962

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior Clinical Associate

Salary

Location

Spain, Madrid

Location

Barcelona

Madrid

Remote Working

Office or Home

Business Area

ICON Strategic Solutions

Job Categories

Early Phase Services

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Associate to join our diverse and dynamic team. As a Senior Clinical Associate at ICON, you will play a critical role in overseeing and supporting the execut

Reference

JR144294

Expiry date

01/01/0001

Ana Guerra Garaeta Read more Shortlist Save this role
Study Delivery Manager

Salary

Location

Bulgaria, Sofia

Location

Sofia

Prague

Warsaw

Bucharest

Remote Working

Office or Home

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successfu

Reference

JR142657

Expiry date

01/01/0001

Orsolya Berke

Author

Orsolya Berke
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above