Study Start Up Associate I job in

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

ICON are currently hiring a Study Start Up Associate

Office based in Milan

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 year 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 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

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.

If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com.

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.
Learn more about Our Culture at ICON

List #1

Day in the life

Two medics at ICON clinical research clinic

The Strategic Role of Site Selection and Activation in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

10/28/2025

Summary

Precision at the Outset: The Strategic Role of Site Selection and Activation in Clinical Trials The success of any clinical trial begins well before the first patient is enrolled. Behind every sit

Teaser label

Explore the critical role of site selection and activation in clinical trials.

A Career Focused on Patients: Daniela's Journey at ICON

Teaser label

Our People

Content type

Blogs

Publish date

10/27/2025

Summary

Daniela’s Journey at ICON Daniela Gutierrez’s career at ICON has been a journey of transition, determination, and purpose. What began as a role in study start-up has evolved into a position deeply

Teaser label

Daniela shares insights into how collaboration, purpose, and innovation drive every part of her work.

ICON Careers Spotlight: Chris Maguire, Director of Finance Business Partnering

Teaser label

Our People

Content type

Blogs

Publish date

10/15/2025

Summary

Chris Maguire’s Journey at ICON Over the past eight years at ICON, Chris Maguire has held six roles within the finance function, each expanding his expertise and sharpening his ability to support

Teaser label

Discover how Chris Maguire’s collaborative approach has shaped a rewarding career journey at ICON.

View all

Similar jobs at ICON

(Sr) Clinical Trial Manager

Salary

Location

Taiwan, Taipei

Location

Taipei

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of

Reference

JR136990

Expiry date

01/01/0001

Author

Sandy Tang

Author

Sandy Tang

Read more Shortlist Save this role

CTA 1

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team. As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and a

Reference

JR138319

Expiry date

01/01/0001

Author

Rita Villavicencio

Author

Rita Villavicencio

Read more Shortlist Save this role

Drug Safety associate

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Drug Safety Associate to join our diverse and dynamic team. As a Drug Safety Associate at ICON, you will play a pivotal role in ensuring the safety of investigational drugs

Reference

JR138519

Expiry date

01/01/0001

Author

Rita Villavicencio

Author

Rita Villavicencio

Read more Shortlist Save this role

Drug Safety associate

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Drug Safety Associate to join our diverse and dynamic team. As a Drug Safety Associate at ICON, you will play a pivotal role in ensuring the safety of investigational drugs

Reference

JR138523

Expiry date

01/01/0001

Author

Rita Villavicencio

Author

Rita Villavicencio

Read more Shortlist Save this role

Graduate Pharmacovigilance Associate

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

We are currently seeking a Graduate Pharmacovigilance Associate to join our diverse and dynamic team. As a Graduate Pharmacovigilance Associate at ICON, you will play an essential role in supporting t

Reference

JR138518

Expiry date

01/01/0001

Author

Rita Villavicencio

Author

Rita Villavicencio

Read more Shortlist Save this role

CSA

Salary

Location

Brazil, Sao Paulo

Department

Clinical Monitoring

Location

Sao Paulo

Remote Working

Office Based

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

JR136982

Expiry date

01/01/0001

Author

Olivia Molina

Author

Olivia Molina

Read more Shortlist Save this role

About Icon

Overview of Service Lines

Full Service

ICON Strategic Solutions

Global Business Services

Global Office Locator

Inclusion & Belonging

ICON Cares - ESG

Why icon? full service mean for you?

Building a Successful Clinical Research Resume

Landing Your First Job in Clinical Research

graduate What does full service mean for you?

Study Start Up Associate I

About the role

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

ICON and you

About ICON

Career Pathways

Benefits & Rewards

Inclusion & Belonging

Environmental, Social & Governance

Global Office Locator

Impactful work. Meaningful careers. Quality rewards.