JUMP TO CONTENT

Contract and Submissions specialist.

  1. Italy
2023-105388
  1. ICON Strategic Solutions
  2. Contracts Administration
  3. Remote

About the role

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

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, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


We are looking fora Clinical Contract Analyst who has experience in execute and oversee clinical trial country submissions and approvals, contracts and budgets. 

 

What you will be doing:

Manage Clinical Contracts and Nondisclosure Agreement (NDA) process for Global trials:


▪ Serve as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements, Ancillary Services Agreements, Consultant Agreements and other clinical contracts.
▪ Process all clinical contract requests and help facilitate early execution through the Contract Management System.
▪ Serve as primary contact for Client during contract negotiation phase.
▪ Perform consistent quality audits of work output and document knowledge base as needed.
▪ Maintain contract tracking on SharePoint site and other systems used to manage contract and budget files.

 

Negotiate Clinical Site Contracts & Budgets


For Sites Managed by Client:


▪ Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract.
▪ Work closely with study teams to develop country budget templates tailored for each study.
▪ Negotiate and manage consistent site budgets that will assist in early site activation.
▪ Ensure consistency in site payment schedules and terms to facilitate the payment system.
▪ Respond to queries related to contracts and budgets.
▪ Manage the contract escalation process to appropriate individuals, as needed.
▪ Establish good customer relations with sites starting with the primary point of contact for budgets and contracts.
▪ Analyze contract trends using available tools and assist with developing team metrics with regard to contract timelines.


For Sites Managed by a CRO:


▪ Review and approve the master Investigator Fee template developed by CRO for each study before distribution to sites
▪ Manage the final execution of site clinical contracts handled by a CRO and track the contract process for each study with a CRO.
▪ Serve as escalation point of contact for budget escalations from CRO.
▪ Provide contract/budget comments to CRO on an as needed basis.
▪ Respond to CRO queries for previously negotiated site contracts to ensure consistency with contract language and budget line items.


Other:

 

Execute and oversee clinical trial country submissions and approvals.

▪ Develop written processes relevant to the scope of work listed above as needed.
▪ Contribute to team efforts for continuous process improvements.
▪ Adhere to Clinical Operations or project specific quality documents (e.g., SOPs, work practices, training guides), as applicable.
▪ Participate in the development and testing of relevant tools and procedures.
▪ Workflow management.


Qualifications: 

 

Education and Experience

  • Bachelor’s degree in Life Science, Business or equivalent.
  • Minimum 3 years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist.
  • Experience negotiating contract payment terms and clinical budgets and submissions.
  • Intermediate Excel and database management skills.
  • Knowledge of GCP/ICH requirements.
  • Excellent analytical and problem solving skills.
  • Requires effective organizational and communication skills.
  • Work both independently and ability to successfully work in a “virtual” team environment.
  • Has a track record of exceeding goals successfully.
  • Partners with others to get work done.
  • Follows through on commitments.
  • Shows personal commitment and takes action to continuously improve.
  • Deals constructively with problems that do not have clear solutions or outcomes.
  • Maintains a positive attitude despite adversity.
  • Acquires data from multiple and diverse sources when solving problems.
  • Fluent in Italian and English.
  • Must have sponsor side experience negotiating clinical trial contracts and clinical budgets with Sites


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
Salary: Let’s talk about it.

Teaser label

Career Progression

Content type

Blogs

Publish date

12/21/2022

Summary

Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune

Teaser label

Things to consider heading into 2023 if you're thinking about moving jobs.

Read more
Jamie Kempski

by

Jamie Kempski

Jamie Kempski

by

Jamie Kempski

View all

Similar jobs at ICON

Clinical Budget and Contract Management Associate

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

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

2025-116569

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Contract Analyst II

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

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

2025-116535

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
Contract Analyst 2

Salary

Location

Mexico

Department

Clinical Operations Roles

Location

Mexico

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

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

2025-116254

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
Clinical Vendor Contract Manager

Salary

Location

United Kingdom, Bulgaria, Hungary, Czech Republic

Department

Clinical Operations Roles

Location

Bulgaria

Czech Republic

Hungary

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

Job Type

Permanent

Description

As a Vendor Contracts Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-116327

Expiry date

01/01/0001

Rajvir Samra

Author

Rajvir Samra
Read more Shortlist Save this role
Investigator Pricing - Disease Area Lead

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

Job Type

Permanent

Description

As a Investigator Pricing Disease Area Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-115355

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
Sr. Contract Specialist

Salary

Location

Czech Republic

Department

Clinical Operations Roles

Location

Czech Republic

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Contracts Administration

Job Type

Permanent

Description

As a (job title) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2024-115877

Expiry date

01/01/0001

Jaroslav Polák Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above