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

People talking in a meeting
Networking Strategies in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

06/06/2025

Summary

Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s

Teaser label

Discover how strategic networking can strengthen collaboration, and support your clinical research career journey.

Read more
Blood cancer cells
Blood Cancer Day - Raising Awareness and Driving Change

Teaser label

Industry

Content type

Blogs

Publish date

05/29/2025

Summary

Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,

Teaser label

Learn how clinical research is transforming the future for those affected by hematological cancers.

Read more
Silver ribbon
Recognising World Schizophrenia Day through Research and Compassion

Teaser label

Industry

Content type

Blogs

Publish date

05/22/2025

Summary

World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ

Teaser label

Explore how ICON is advancing schizophrenia research and addressing stigma through clinical innovation.

Read more
View all

Similar jobs at ICON

Clinical Research Coordinator

Salary

Location

Poznan

Location

Poznan

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research Site Services

Job Type

Permanent

Description

The Clinical Research Coordinator is responsible for supporting Investigator Site staff in conducting clinical research studies according to project-specific requirements and regulatory guidelines.The

Reference

JR128148

Expiry date

01/01/0001

Jacek Jaworski Read more Shortlist Save this role
Senior Clinical Associate

Salary

Location

China, Shanghai

Location

Beijing

Shanghai

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Early Phase Services

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Associate to join our diverse and dynamic team. As a Senior Clinical Associate at ICON, you will play a critical role in overseeing and supporting the execut

Reference

JR131035

Expiry date

01/01/0001

Jessica Zhong

Author

Jessica Zhong
Read more Shortlist Save this role
Senior Clinical Trial Manager

Salary

Location

France

Department

Clinical Trial Management

Location

France

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

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

Reference

2025-119844

Expiry date

01/01/0001

Vanessa Verdickt Read more Shortlist Save this role
Principal Statistical Programmer

Salary

Location

United Kingdom, Belgium, Poland, Bulgaria, South Africa, Spain

Department

Biometrics Roles

Location

Belgium

Bulgaria

Poland

South Africa

Spain

UK

Business Area

ICON Strategic Solutions

Job Categories

Programming

Job Type

Permanent

Description

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

Reference

2025-120177

Expiry date

01/01/0001

Jack Fisher

Author

Jack Fisher
Jack Fisher

Author

Jack Fisher
Read more Shortlist Save this role
Principal Biostatistician

Salary

Location

South Africa, Johannesburg

Location

Johannesburg

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Biostatistician

Job Type

Permanent

Description

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

Reference

JR128495

Expiry date

01/01/0001

Sophia Cairns

Author

Sophia Cairns
Read more Shortlist Save this role
Technical Application Project Manager

Salary

Location

Bangalore

Department

Biometrics Roles

Location

Bangalore

Business Area

ICON Strategic Solutions

Job Categories

Clinical Data Management

Clinical Data Scientist Lead

Clinical Systems

Data Standards Consultant

Job Type

Permanent

Description

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

Reference

2025-119239

Expiry date

01/01/0001

Abhisikta Mishra Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above