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 see similar roles below...

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

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
Headshot of Stephen Cameron
From Algorithms to Outcomes: Stephen’s Journey in Clinical Data Science

Teaser label

Our People

Content type

Blogs

Publish date

01/02/2025

Summary

In the world of clinical research, data is more than just numbers - it’s the key to unlocking better patient outcomes, advancing therapies, and shaping the future of healthcare. To explore this fascin

Teaser label

Stephen, Clinical Data Science Director, shares insights on transforming clinical research with data-driven innovations.

Read more
Medics in a room talking
Communication Strategies for Sites and Sponsors

Teaser label

Industry

Content type

Blogs

Publish date

12/16/2024

Summary

Effective Communication with Sites and Sponsors in Clinical Research Clear and effective communication is the cornerstone of successful clinical research. It fosters collaboration, ensures complia

Teaser label

Discover effective communication strategies for clinical research sites and sponsors.

Read more
View all

Similar jobs at ICON

Medical Research Associate

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinic

Job Type

Permanent

Description

We are currently seeking a Medical Research Associate to join our diverse and dynamic team. As a Medical Research Associate at ICON, you will be responsible for meeting/greeting clinical research volu

Reference

JR125039

Expiry date

01/01/0001

Mitzi Overton

Author

Mitzi Overton
Mitzi Overton

Author

Mitzi Overton
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Nurse I

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Nurse

Job Type

Temporary Employee

Description

We are currently seeking a Clinical Research Nurse I to join our diverse and dynamic team. As a Clinical Research Nurse I at ICON, you will play a pivotal role in supporting the execution of clinical

Reference

JR127358

Expiry date

01/01/0001

Mitzi Overton

Author

Mitzi Overton
Mitzi Overton

Author

Mitzi Overton
Read more Shortlist Save this role
Read more Shortlist Save this role
Optometrist - Johns Creek GA

Salary

Location

United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

As a Optometrist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This position is located in Johns Creek, GA.

Reference

2025-116331

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
Nuclear Medicine Authorized User / Clinical Research Physician

Salary

Location

US, Salt Lake City (PRA)

Location

Salt Lake City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Physician

Job Type

Permanent

Description

We are currently seeking a Nuclear Medicine Authorized User/Clinical Research Physician to join our diverse and dynamic team. In this role, you will provide essential medical input for study protocols

Reference

JR124034

Expiry date

01/01/0001

Jasmine Garcia

Author

Jasmine Garcia
Jasmine Garcia

Author

Jasmine Garcia
Read more Shortlist Save this role
Read more Shortlist Save this role
Site Services Specialist I

Salary

Location

Mexico, Mexico City

Department

Full Service - Development & Commercialisation Solutions

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research In-Home Services

Job Type

Permanent

Description

We are currently seeking a Site Services Specialist I to join our diverse and dynamic team. As a Site Services Specialist I at ICON, you will play a key role in supporting clinical trial sites by mana

Reference

JR126808

Expiry date

01/01/0001

Daniela Guerrero

Author

Daniela Guerrero
Daniela Guerrero

Author

Daniela Guerrero
Read more Shortlist Save this role
Read more Shortlist Save this role
CRA

Salary

Location

London

Department

Clinical Operations Roles

Location

London

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

Scotland or Northern UK-Based In Vitro Diagnostics CRA required to augment existing team of IVD CRAs. Target candidate profiles are >BSc educated UK-based experienced CRAs to monitor at sites in Scotl

Reference

2025-116647

Expiry date

01/01/0001

Dominic Brady

Author

Dominic Brady
Dominic Brady

Author

Dominic Brady
Read more Shortlist Save this role
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above