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

female pharmacist selecting medicine
Careers in Pharmacovigilance: Opportunities in Patient Safety and Drug Development

Teaser label

Industry

Content type

Blogs

Publish date

08/25/2025

Summary

Careers in Pharmacovigilance Pharmacovigilance, also known as drug safety, is one of the most important pillars of modern medicine. It ensures that once a medicine is developed, tested, and appro

Teaser label

Learn the skills that open doors to a career in drug safety and development.

Read more
Headshot of female
Leadership in Mexico: Karen Hahn’s Journey at ICON

Teaser label

Our People

Content type

Blogs

Publish date

08/14/2025

Summary

A Leader’s Journey: Karen Hahn on Growth, Culture and the Future of ICON Mexico Karen Hahn’s career at ICON has unfolded over more than 15 years, shaped not by a rigid plan, but by openness to ch

Teaser label

Over 15 years, Karen Hahn has grown alongside ICON Mexico - from a team of 40 in 2010 to over 2,000 today.

Read more
Headshot of female
Building a Career at ICON: Susie's journey from HR Analyst to Senior VP

Teaser label

Inside ICON

Content type

Blogs

Publish date

08/07/2025

Summary

Building a Career at ICON: A Conversation with Susie McEvoy, Senior VP of HR At ICON, career journeys are rarely linear – and Susie McEvoy’s story is a powerful example of that. From joining as a

Teaser label

Discover how Susie built a successful career at ICON, progressing from HR Analyst to Senior Vice President.

Read more
View all

Similar jobs at ICON

Clinical Research Lead

Salary

Location

Ukraine

Department

Clinical Trial Management

Location

Ukraine

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

We are hiring a Clinical Research Lead, sponsor dedicated in Ukraine.Our client is a medicine company turning science into healing to make life better for people around the world. Would you like to be

Reference

2025-121725

Expiry date

01/01/0001

Orsolya Berke

Author

Orsolya Berke
Orsolya Berke

Author

Orsolya Berke
Read more Shortlist Save this role
Read more Shortlist Save this role
SMA I

Salary

Location

Tallinn

Department

Clinical Monitoring

Location

Tallinn

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a SMA I/ II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-121354

Expiry date

01/01/0001

Zalkina Lomber

Author

Zalkina Lomber
Zalkina Lomber

Author

Zalkina Lomber
Read more Shortlist Save this role
Read more Shortlist Save this role
Financial Analyst II

Salary

Location

India, Chennai

Location

Chennai

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

What You Will Be Doing:Set up and maintain project records in Oracle, P&F and OMR systems, including updates for scope changes, budget revisions and status trackingCollaborate with finance, project ma

Reference

JR133805

Expiry date

01/01/0001

Chethana Nelliadka Kamalaksha

Author

Chethana Nelliadka Kamalaksha
Chethana Nelliadka Kamalaksha

Author

Chethana Nelliadka Kamalaksha
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior CDC/CDC II

Salary

Location

India, Bangalore

Location

Bangalore

Chennai

Bengaluru

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Management

Job Type

Permanent

Description

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

Reference

JR131289

Expiry date

01/01/0001

Swathy Anandan

Author

Swathy Anandan
Swathy Anandan

Author

Swathy Anandan
Read more Shortlist Save this role
Read more Shortlist Save this role
CTA

Salary

Location

Poland

Department

Clinical Operations Roles

Location

Poland

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

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

Reference

2025-121753

Expiry date

01/01/0001

Zalkina Lomber

Author

Zalkina Lomber
Zalkina Lomber

Author

Zalkina Lomber
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate, UK

Salary

Location

Reading

Department

Clinical Trial Management

Location

Reading

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

Experienced UK-based Regional CRA/clinical research associate required to augment existing CRA team, for multinational biopharmaceutical company partner. You will be part of an innovative and global B

Reference

2025-121901

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