Study Start Up Associate I - Italy job in

This vacancy has now expired. Please see similar roles below...

Study Start Up Associate

The Study Start Up Associate is responsible for the preparation and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards. Also responsible for the 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.

Job Functions and Responsibility

Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
Prepare, review and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
Develop and finalize Country Specific SIS/ ICFs.
Prepare and finalize Country Specific xml files (if applicable for region).
Review and translate Drug Labels
Perform independent quality review of submission packages.
Collect and maintain 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 (if applicable for region).
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 timely follow-up for queries made by CA/EC.
Responsible for the collection of critical documents required for IP Release.
Attend study team meetings as required.
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.
Be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs.
Assist and provide support to the Study Start Up Lead to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.
Undertake other reasonably related duties as may be assigned from time to time.
Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings

Experience Skills and Knowledge Required

Prior relevant experience and/or understanding of clinical study start up requirements and activities.
Good organizational skills and the ability to manage multiple tasks.
An excellent level and proven experience of high standards of attention to detail.
Good written and verbal communication skills. Proficient in English and language required for country assignments.
Ability to be customer focused is essential.
Logical and critical thinking skills.
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.

Education Requirements

High School diploma, or local equivalent, required. Bachelors degree, or local equivalent, preferred.

*LI-AC1.

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Reasonable Accomodations

List #1

Day in the life

Shining a Light on Endometriosis Awareness Month

Teaser label

Inside ICON

Content type

Blogs

Publish date

04/18/2024

Summary

Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis

Teaser label

Endometriosis Awareness Month sheds light on this often-misunderstood condition affecting millions worldwide.

The Role of Data Management in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

04/18/2024

Summary

Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials

Teaser label

This blog examines the critical role of data management in clinical trials.

Navigating the Clinical Research Supply Chain

Teaser label

Industry

Content type

Blogs

Publish date

04/12/2024

Summary

Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ

Teaser label

Discover the intricate workings of the clinical research supply chain in this comprehensive guide.

View all

Similar jobs at ICON

Senior CRA

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2024-109993

Expiry date

01/01/0001

Author

Michal Czyrek

Author

Michal Czyrek

Read more Shortlist Save this role

Clinical Research Associate

Salary

Location

Turkey

Department

Clinical Monitoring

Location

Turkey

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

2023-104179

Expiry date

01/01/0001

Read more Shortlist Save this role

Senior CRA

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 Sanquiz

Author

Tulio Sanquiz

Read more Shortlist Save this role

Clinical Trial Manager

Salary

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 Sanquiz

Author

Tulio Sanquiz

Read more Shortlist Save this role

Principal Biostatistician

Salary

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

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

Read more Shortlist Save this role

Principal Medical Writer

Salary

Location

Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland

Department

Medical Affiars & Medical Writing Roles

Location

Belgium

Denmark

France

Germany

Netherlands

Spain

Switzerland

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 Roth

Author

Natalia Roth

Read more Shortlist Save this role

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

Why icon? full service mean for you?

graduate What does full service mean for you?

Study Start Up Associate I - Italy

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are