JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

TMF Lead

042780_2

About the role

This vacancy has now expired. Please click here to view live vacancies.
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.
 
Overview of the Role
  • You will be responsible to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
  • You will determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
  • You will assess impact of potential changes to TMF specifications prior to implementation and collaborating with CPM if modifications are necessary.
  • You will review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
  • You will serve as a point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues and product defense.
Role Requirements
  • You will possess a Bachelor’s Degree or equivalent degree/experience.
  • You must have clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
  • You must have project management, resource management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • You must have experience supporting regulatory submissions and inspections preferred.   Strong skills in negotiation and conflict resolution essential too.  
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  Your dedicated recruiter will discuss this information with you during your phone interview.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
List #1

Day in the life

Headshot of male
Leading Through Change: Zhong Yao's Journey at ICON in China

Teaser label

Our People

Content type

Blogs

Publish date

12/10/2025

Summary

Zhong Yao's Journey at ICON Plc in China Zhong Yao's career in clinical research spans over two decades, with leadership roles across major CROs and a commitment to advancing healthcare in China.

Teaser label

From culture to collaboration, Zhong Yao explains how ICON China delivers quality clinical trials, and empowers local talent.

Read more
Two computer monitors with data graphs
How Data Moves Through a Clinical Trial

Teaser label

Industry

Content type

Blogs

Publish date

12/01/2025

Summary

How Data Moves Through a Clinical Trial Clinical research depends on one essential element: trustworthy data. Every safety decision, every statistical conclusion and every regulatory submission i

Teaser label

Discover how data flows through a clinical trial and learn where your skills could fit within clinical research.

Read more
Male and female auditing a manufacturing facility
Quality and Compliance - A Plain Language Guide

Teaser label

Industry

Content type

Blogs

Publish date

11/28/2025

Summary

Quality and Compliance for New Entrants:           A Plain Language Guide Quality and compliance can feel like dense subjects when you are entering clinical research for the first time. Many job

Teaser label

A clear, practical introduction to quality and compliance for those starting a career in clinical research.

Read more
View all

Similar jobs at ICON

Patient & Site Engagement Operations Specialist

Salary

Location

US, Blue Bell (ICON)

Location

Raleigh

Georgia

Texas

California

Blue Bell

Chicago, IL

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Patient Recruitment

Job Type

Permanent

Description

We are currently seeking a Patient Recruitment Lead to join our diverse and dynamic team. As a Patient Recruitment Lead at ICON, you will play a critical role in driving patient recruitment strategies

Reference

JR140650

Expiry date

01/01/0001

Brandon Pupek

Author

Brandon Pupek
Brandon Pupek

Author

Brandon Pupek
Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II, West Coast or Midwest

Salary

Location

Utah

Location

Utah

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing cli

Reference

JR140447

Expiry date

01/01/0001

Jamie Pruitt

Author

Jamie Pruitt
Jamie Pruitt

Author

Jamie Pruitt
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Trial Manager

Salary

Location

US, Blue Bell (ICON)

Location

Blue Bell

Remote Working

Office or Home

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successfu

Reference

JR134818

Expiry date

01/01/0001

Melissa Benner

Author

Melissa Benner
Melissa Benner

Author

Melissa Benner
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate

Salary

Location

United States of America

Location

Multiple US Locations

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical

Reference

JR140605

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Lead Clinical Research Associate

Salary

Location

United States of America

Location

Multiple US Locations

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical trial si

Reference

JR140552

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate

Salary

Location

United States of America

Location

Multiple US Locations

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activit

Reference

JR140542

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above