JUMP TO CONTENT

Sr Study Start Up Associate

JR063792

About the role

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

At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for someone with strong study start up experience to join our Study Start Up group. Our Study Start Up associates are integral in ensuring that physicians at research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
Summary
Senior Study Start Up Associate understands client objectives and assist the Study Start Up Team Lead in the development of the plan for country and site distribution an their assigned countries, while performing assigned study start up activities. This person acts as a deputy for the country Study Start Up Manager as appropriate.
Job Description
* Attendance at Bid Defense, ,Kick-Off,Investigator or study team meetings
* Perform feasibility , site-identification ,site contract negotiation, and other study start up activities assigned
* ·Provide country specific Study Start Up expertise to Study Stan 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 Sheet and Informed Consent Forms.
* Review and translate Drug labels
* 'Perform independent quality review of submission packages
* Perform timely and accurate data entry of all relevant Study Stan Up activities into the appropriate clinical trial management system
* Responsible for the timely follow-up of queries made by EC/CA
* Responsible for the collection of critical documents required for IP Release
* Responsible for the budget,negotiation execution and tracking of contract with sites.
*·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 organizations,for the assigned countries.
*·To be familiar with ICH-GCP, and relevant country regulations/guidelines and ICON SOPs
* Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable
* Develop end maintain effective relationships with local,regional and country authorities

Role Requirements

  • Bachelor's Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
  • Global clinical trials experience with awareness of global regulatory requirements for clinical site initiation documents
  • Proven experience handling study start ups for more than 2+ years

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin

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

07/07/2025

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.

Read more
3 x Digital padlocks
The Role of Cybersecurity in Clinical Data Management

Teaser label

Industry

Content type

Blogs

Publish date

07/04/2025

Summary

Cybersecurity in Clinical Data Management In clinical research, data is both a vital asset and a significant responsibility. As trials become increasingly digitised and decentralised, the protectio

Teaser label

Learn about the critical role cybersecurity plays in an increasingly digital research environment.

Read more
Stethoscope on paper
Specialisations in Clinical Research: Finding Your Niche

Teaser label

Industry

Content type

Blogs

Publish date

07/03/2025

Summary

Finding the Specialisation for You Clinical research is a dynamic, multidisciplinary field that brings together scientific innovation, operational rigour and patient-centric thinking. While many

Teaser label

Explore the diverse specialisations in clinical research, from clinical operations to data management, regulatory affairs, and beyond.

Read more
View all

Similar jobs at ICON

Senior Clinical Scientist - Oncology

Salary

Location

United States, Canada

Department

Clinical Trial Management

Location

Canada

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Senior Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Senior Clinical Scientist will support l

Reference

2025-120685

Expiry date

01/01/0001

Melissa Benner Read more Shortlist Save this role
Study Support Assistant ( Torreón)

Salary

Location

Mexico City

Department

Study Start Up

Location

Mexico City

Business Area

ICON Strategic Solutions

Job Categories

Study Start Up

Job Type

Permanent

Description

As a Study Support Assistant  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence

Reference

2025-120464

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
Clinical Trial Liaison

Salary

Location

Canada

Department

Clinical Trial Management

Location

Canada

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

The Clinical Trial Liaison (CTL) role is designed to transform the clinical research site experience by making the customer experience a priority. This strategic role serves as a critical interface be

Reference

2025-120769

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Clinical Trial Liaison

Salary

Location

United States

Department

Clinical Trial Management

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

The Clinical Trial Liaison (CTL) role is designed to transform the clinical research site experience by making the customer experience a priority. This strategic role serves as a critical interface be

Reference

2025-120768

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Director, Imaging Operations/Sr. Targeted Alpha Therapeutic Expert

Salary

Location

United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

As a Sr. TAT (Targeted Alpha Therapeurics) Expert you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120518

Expiry date

01/01/0001

Melissa Benner Read more Shortlist Save this role
Clinical Research Associate - IMM/Cross TA - Chicago, IL (Field Based)

Salary

Location

Chicago

Department

Clinical Monitoring

Location

Chicago

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119487

Expiry date

01/01/0001

Monica Hawkins Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above