JUMP TO CONTENT

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

Nurse and patient
Understanding Roles in a Clinical Trial: Sponsors, CROs, and Sites

Teaser label

Industry

Content type

Blogs

Publish date

02/16/2026

Summary

What Sponsors, CROs, and Sites Each Do Clinical research brings together many organisations, each with a specific role in delivering a clinical trial. For those new to the industry, the relationsh

Teaser label

Learn how clinical trials are delivered by understanding the roles of sponsors, CROs, and sites.

Read more
Headshot of female
From Lab Bench to Program Leadership: Sinéad McKeon's Career at ICON

Teaser label

Our People

Content type

Blogs

Publish date

02/05/2026

Summary

Building expertise through diverse roles and continuous learning Sinéad McKeon's career at ICON demonstrates how scientific training can evolve into strategic leadership. Now a Senior Manager in Lab

Teaser label

Discover how a career can evolve from hands on lab work to program management in this interview with Sinéad McKeon.

Read more
Headshot image of male
Shaping the Future of Patient Safety: A Conversation with Hassan Aljobori

Teaser label

Our People

Content type

Blogs

Publish date

02/05/2026

Summary

Shaping the Future of Patient Safety At ICON, patient safety is the foundation of everything we do. Hassan Aljobori, Director of Pharmacovigilance, shares his journey through nine years of growth

Teaser label

Hassan shares his career journey, advice for building a career in pharmacovigilance, and what sets ICON apart as an employer.

Read more
View all

Similar jobs at ICON

Sr Clinical Research Coordinator - (Vaccine & Internal Med)

Salary

Location

US, Cary, NC

Department

Accellacare Site Network

Location

Cary

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research In-Home Services

Clinic

Job Type

Permanent

Description

This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site net

Reference

JR142126

Expiry date

01/01/0001

Sasha Brown

Author

Sasha Brown
Sasha Brown

Author

Sasha Brown
Read more Shortlist Save this role
Senior Manager, Site Identification

Salary

Location

US, Blue Bell (ICON)

Department

Accellacare Site Network

Location

Blue Bell

Remote Working

Remote or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

This role is with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site net

Reference

JR139212

Expiry date

01/01/0001

Sasha Brown

Author

Sasha Brown
Sasha Brown

Author

Sasha Brown
Read more Shortlist Save this role
Clinical Site Manager II (Sr CRA)

Salary

Location

Spain, Madrid

Location

Madrid

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

JR145265

Expiry date

01/01/0001

Lola Pombo

Author

Lola Pombo
Lola Pombo

Author

Lola Pombo
Read more Shortlist Save this role
Clinical Site Manager II (Sr CRA)

Salary

Location

Spain, Barcelona

Location

Barcelona

Madrid

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

JR145264

Expiry date

01/01/0001

Lola Pombo

Author

Lola Pombo
Lola Pombo

Author

Lola Pombo
Read more Shortlist Save this role
Clinical Trial Assistant

Salary

Location

Bulgaria, Sofia

Location

Sofia

Remote Working

Hybrid

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Assistant to join our diverse and dynamic FSP team.As a Clinical Trial Assistant at ICON, you will play a pivotal role in assisting with the design and analys

Reference

JR144466

Expiry date

01/01/0001

Dariusz Sternlicht Read more Shortlist Save this role
Financial Accountant II – ICON Finance Projects (18 months fixed-term)

Salary

Location

Ireland, Dublin

Department

Full Service - Corporate Support

Location

Dublin

Remote Working

Hybrid

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Temporary Employee

Description

ICON is seeking a Financial Accountant II – ICON Finance Projects (18 months fixed-term) to join our dynamic finance team and play a pivotal role in our global transformation program. This position is

Reference

JR144688

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above