JUMP TO CONTENT

Senior Study Start Up Associate

  1. Sweden
2025-120982
  1. Study Start Up
  2. ICON Strategic Solutions
  3. Home-Based

About the role

As a Senior Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.  Your key responsibilities will be the preparation and the submission of the submission package to the Ethics Committee, including the local Informed Consent Form preparation.


Responsibilities include:

  • Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned. Distribute and collect CDAs for potential study sites.
  • Provide country-specific study start-up expertise to study start-up team leads and project teams. Create study start-up document templates.
  • 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 (SIS)/ICFs.
  • Review and translate drug labels.
  • Perform independent quality review of submission packages.
  • Responsible for the translation and coordination of translations for documents required for submission.
  • Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.
  • Copy and route incoming correspondence, internal documentation, etc, as appropriate.
  • Responsible for the timely follow up for queries made by EC/competent authority (CA).
  • Coordinate and create documents and material needed to support SIV
  • Responsible for the collection of critical documents required for IP release.
  • Responsible for the dispatch, negotiation, execution, and tracking of contract with sites and other sites, as appropriate.
  • Responsible for the timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS in assigned countries.
  • Attend study team meetings as required, including Kick-Off Meeting.
  • Responsible for the collection and maintenance of the current regulatory/CA and EC submission information 

 

 


You will need:

  • 2 – 4 years of experience in a Study Start Up role
  • To be familiar with ICH GCP, relevant country regulations/guidelines

  • Competent in communication and influencing skills to ensure issue resolution

  • Ability to Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable.

  • Experieence in developing and maintain effective relationships with local, regional, and country authorities.

  • Ability to undertake other reasonably related duties as may be assigned from time to time e.g. protocol amendment submissions, Investigator site budget negotiation, if required

  • Candidates must be based in Sweden, with fluent Swedish language skills and strong knowledge of Swedish clinical regulations


    What ICON can offer you:

     


Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

Similar jobs at ICON

Study Start Up Associate I

Salary

Location

India, Bangalore

Location

Bangalore

Auckland

Bengaluru

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

We are currently seeking a Study Start Up Associate I to join our diverse and dynamic team. As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clin

Reference

JR132646

Expiry date

01/01/0001

Amrutha Saidala Read more Shortlist Save this role
Site Selection Lead

Salary

Location

Poland, Warsaw

Location

Sofia

Warsaw

Johannesburg

Tbilisi

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Role Summary:The Site Selection lead will provide functional leadership for the Site Selection process based on the approved country and site strategy. The Site Selection Lead will liaise with PM, CTM

Reference

JR133565

Expiry date

01/01/0001

Jaziara Hancox Read more Shortlist Save this role
Study Support Assistant

Salary

Location

India, Chennai

Location

Bangalore

Chennai

Bengaluru

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

We are currently seeking a Study Support Assistant to join our diverse and dynamic team. As a Study Support Assistant at ICON, you will play a pivotal role in providing administrative and operational

Reference

JR131993

Expiry date

01/01/0001

Kashifa Tahseen Read more Shortlist Save this role
Study Start-Up Associate I

Salary

Location

Argentina

Department

Study Start Up

Location

Argentina

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Study Start Up

Job Type

Permanent

Description

The Study Start-Up Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accorda

Reference

2025-119739

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Site Selection Specialist

Salary

Location

Poland, Gdansk

Location

Prague

Paris

Johannesburg

Barcelona

Basel

Ankara

Bratislava

Gdansk

Livingston

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Role Summary:The Site Selection Specialist will contact and build relationships with study investigators/sites and networks in assigned areas for the conduct of feasibility and potential study partici

Reference

JR133659

Expiry date

01/01/0001

Persis Davis

Author

Persis Davis
Read more Shortlist Save this role
Site Selection Specialist

Salary

Location

UK, Livingston

Location

Livingston

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

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 It

Reference

JR132143

Expiry date

01/01/0001

Persis Davis

Author

Persis Davis
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above