JUMP TO CONTENT

Senior eTMF Specialist

  1. UK
2024-110971
  1. Clinical Trial Support
  2. ICON Strategic Solutions
  3. Remote

About the role

This vacancy has now expired. Please see similar roles below...

Title - Senior eTMF Specialist

Location - UK, homebased

Sponsor dedicated

 

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


The Senior eTMF Specialist is the subject area expert of both eTMF and TMF. They'll be a member of internal center of excellence to maintain our clients process and knowledge, and manages the outsourcing vendor to perform according to the service level agreement and our clients business requirements.

 

In this role you will be responsible for the following tasks:

 

  • Write processes to describe system functionality. 
  • Supports the study teams regarding initial eTMF activities, for example, set-up of study specific TMF Plan for any given study
  • Oversees the vendor activities and addresses issues with vendor
  • Provides eTMF process guidance and inputs for improvements
  • Interprets the TMF business rules into technical system requirements
  • Contributes to or leads or supports eTMF enhancement projects
  • Provides mentorship and training to new and less experienced staff
  • Monitors, plans and coordinates eTMF process improvement implementation
  • Responsible for change control and validation activities
  • Development of best practices documents, user guides and internal training materials
  • Supports GCDO Q&C activities to develop and monitor the eTMF quality metrics
  • Performs project management and process governance activities when delegated by eTMF Global Lead
  • Participates in eTMF audits and inspections
  • Subject matter expert for QSD creation and update

To be successful in this role, you'll need to have the following:

 

  • Senior TMF management expertise and experience in Veeva Vault Clinical
  • Knowledge regarding TMF metrics and QC activities of EU CTR submission documents would be preferable but not mandatory
  • Bachelor degree plus 5 years’ experience in Clinical Development coupled with 2 years required experience with TMF, or Associates degree plus 7 years' experience in Clinical Development coupled with 2 years required experience with TMF or High School Diploma plus 9 years' experience in Clinical Development coupled with 2 years required experience with TMF.
  • Strong English and communication skills, both written and verbal
  • Must have an advanced level of knowledge of all relevant industry guidance and standards (eg. FDA, EMA, ICH, DIA) as they relate to the creation, exchange and lifecycle management of Trial Master Files.

 

 

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

A person using a pipette
Eliminating outsourcing confusion with ICON's new framework

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/26/2023

Summary

The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j

Teaser label

The CRO market has seen an unmistakable uplift in demand for its services in recent years.

Read more
A picture of holographic images coming out of an iPad
Are remote decentralised clinical trials the future?

Teaser label

Inside ICON

Content type

Blogs

Publish date

10/03/2022

Summary

In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe

Teaser label

In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe

Read more
A picture of a scientist working on an experiment
What are the four phases of a clinical trial?

Teaser label

Inside ICON

Content type

Blogs

Publish date

05/22/2022

Summary

Having enjoyed steady growth over the last several years, it’s predicted that the global clinical trials market will hit a value of $65.2 billion by 2025, and around 58% of this can be attributed to r

Teaser label

Have you ever wondered what's involved in a clinical trial? In this blog post, we take you through each distinct phase.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Clinical Trial Assistant - Home Based

Salary

Location

United States

Department

Clinical Operations Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

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

Reference

2024-111985

Expiry date

01/01/0001

Monica Hawkins Read more Shortlist Save this role
CTA

Salary

Location

Hungary

Department

Clinical Operations Roles

Location

Hungary

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As an important member of the clinical team you will be responsible for administrative support of all study-related activities. This includes start-up activities, study related documentation, logistic

Reference

2024-111997

Expiry date

01/01/0001

Orsolya Berke

Author

Orsolya Berke
Read more Shortlist Save this role
SMA I

Salary

Location

Spain, Barcelona

Department

Clinical Monitoring

Real World Solutions

Location

Barcelona

Madrid

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I

Reference

JR122016

Expiry date

01/01/0001

Lourdes Roy Prats Read more Shortlist Save this role
SMA I

Salary

Location

Hungary

Department

Clinical Operations Roles

Location

Hungary

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

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

Reference

2024-111811

Expiry date

01/01/0001

Orsolya Berke

Author

Orsolya Berke
Read more Shortlist Save this role
IHCRA

Salary

Location

Turkey, Ankara

Department

Clinical Monitoring

Location

Ankara

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

office based position in AnkaraAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and impr

Reference

JR119083

Expiry date

01/01/0001

Tereza Svobodova Read more Shortlist Save this role
Clinical Trial Assistant

Salary

Location

Sydney

Department

Clinical Operations Roles

Location

Sydney

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

Clinical Trial Assistant Location: Office-based/ Hybrid, Sydney (Australia) As Clinical Trial Assistant, you will be joining the world's largest & most comprehensive clinical research organisation, po

Reference

2024-111961

Expiry date

01/01/0001

Joanne Young

Author

Joanne Young
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above