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

Inside ICON Bulgaria: Career Insights from Dimitar Karzhin, Site Head

Teaser label

Our People

Content type

Blogs

Publish date

10/08/2025

Summary

A Career Built on Purpose: Dimitar's Journey at ICON Plc Dimitar Karzhin’s career path is not one he could have predicted. What began with a decade as a practicing General Practitioner in Bulgaria l

Teaser label

Discover valuable career insights and leadership lessons from Dimitar Karzhin, Site Head of ICON Plc Bulgaria.

10 Steps to Building a Professional LinkedIn Profile

Teaser label

Career Progression

Content type

Blogs

Publish date

09/19/2025

Summary

How to Build a Strong LinkedIn Profile That Attracts Employers LinkedIn is no longer just a digital CV. It is a professional network, a space to showcase your skills and a platform to connect with

Teaser label

Discover practical tips on creating a professional profile, networking effectively and growing your career online.

Shaping a Career in Clinical Research

Teaser label

Our People

Content type

Blogs

Publish date

09/16/2025

Summary

Growing with ICON: Christina’s Journey in Clinical Operations and Quality Leadership At ICON, we are proud to showcase the incredible journeys of our colleagues who make a real impact on pati

Teaser label

Read about Christina’s journey from CRA to Clinical Operations Manager at ICON Strategic Solutions.

View all

Similar jobs at ICON

Clinical Operations Manager

Salary

Location

Netherlands, Utrecht, Zen

Department

Clinical Monitoring

Location

Assen

Utrecht

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Operations Management

Job Type

Permanent

Description

We are currently seeking a Clinical Operations Manager (COM) to join our diverse and dynamic team supporting full service. As a COM at ICON, you will play a pivotal role in overseeing the execution of

Reference

JR137120

Expiry date

01/01/0001

Author

Sophie Clarke

Author

Sophie Clarke

Read more Shortlist Save this role

Clinical Operations Manager

Salary

Location

France, Paris

Department

Clinical Monitoring

Location

Paris

Lyon

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Operations Management

Job Type

Permanent

Description

Reference

JR137103

Expiry date

01/01/0001

Author

Sophie Clarke

Author

Sophie Clarke

Read more Shortlist Save this role

Senior Manager, FSA

Salary

Location

Turkey, Ankara

Location

Ankara

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

The Senior Manager, Feasibility & Site Activation (FSA) will lead and develop a team of Site Contracts Negotiators in Turkey, ensuring efficient, high-quality delivery of clinical trial contract activ

Reference

JR134563

Expiry date

01/01/0001

Author

Magda Kozuszek

Author

Magda Kozuszek

Read more Shortlist Save this role

Study Review Specialist I

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Study Review Specialist ILocation: Mexico (Office Based in Mexico City only)As a Study Review Specialist I you will be responsible for reviewing and approve global Critical Package Documents (CDPs) p

Reference

JR131666

Expiry date

01/01/0001

Author

Elizabeth Davies

Author

Elizabeth Davies

Read more Shortlist Save this role

Imaging Specialist

Salary

Location

South Africa, Johannesburg

Department

Full Service - Development & Commercialisation Solutions

Location

Dublin

Lisbon

Johannesburg

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Imaging Specialist

Job Type

Permanent

Description

Are you a qualified Radiographer with Echo Tech experience, looking for an exciting opportunity to work with a Clinical Trial environment?Are you looking for a role that will combine your extensive Ec

Reference

JR134704

Expiry date

01/01/0001

Author

James Smith

Author

James Smith

Read more Shortlist Save this role

Site Activation Lead

Salary

Location

Serbia, Belgrade

Location

Prague

Warsaw

Belgrade

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Site Activation

Job Type

Permanent

Description

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

Reference

JR133914

Expiry date

01/01/0001

Author

Magda Kozuszek

Author

Magda Kozuszek

Read more Shortlist Save this role

About Icon

Overview of Service Lines

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

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.