Lead TMF Specialist
- Colombia
- Clinical Trial Support
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
As a Lead TMF Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be joining one of our global pharmaceutical clients; a prestigious organization, specializing in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
What you will be doing:
- The role independently maintains the Trial Master Files for assigned studies, participating in end-to-end TMF management activities, including adherence to organizational TMF standards and study-level quality control reviews, and facilitating issue resolution.
- Ensure TMF completeness and accuracy based client´s SOPs and regulatory requirements
- Maintain study-level TMFs including QC review, analysis, and vendor oversight (if applicable)
- Conduct content review of a variety of documents in a short time frame while maintaining consistency and attention to detail
- Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with some supervision
- Generate metrics for department and study team usage supporting TMF completeness, timeliness and quality
- Participate in inspection readiness reviews, preparation activity and inspection conduct
- Provide guidance and training as applicable to TMF stakeholders; serve as a resource to colleagues on more advanced TMF activities
- Coordinate onboarding of new staff
- Participate in and may lead projects that require cross-functional collaboration or involve coordinating system updates
You are:
- Bachelors degree in relevant discipline
- Strong verbal/written communication, presentation skills and interpersonal skills to educate/train project teams and other stakeholders and exchange key information
- Effectively communicates and coordinates activities within the group and other TMF stakeholders
- MS Excel, Word, PowerPoint expertise
- Experience working in a TMF platform
- Experience working in a CTMS platform
- Possess strong critical thinking skills with a focus on inspection readiness
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.jpg)
Teaser label
Inside ICONContent type
BlogsPublish 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
.jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label
Inside ICONContent type
BlogsPublish 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
Similar jobs at ICON
Salary
Location
Mexico
Department
Clinical Operations Roles
Location
Mexico
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Site Management Associate Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be part of an innovative a
Reference
2025-119277
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
Germany
Department
Clinical Operations Roles
Location
Germany
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
The Clinical Trials Assistant (CTA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure
Reference
2025-119326
Expiry date
01/01/0001
Author
Roxana RoscaAuthor
Roxana RoscaSalary
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 Trial Support
Job Type
Permanent
Description
The Role:The Technical Data Analyst supports Imaging Science, Project Management, and Radiology in the review and approval of image analysis for data delivery.May assist in the identification of data
Reference
JR127417
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
India, Chennai
Department
Full Service - Development & Commercialisation Solutions
Location
Chennai
Trivandrum
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
We are currently seeking a Customer Service Rep to join our diverse and dynamic team. As a Customer Service Rep at ICON, you will play a pivotal role in providing exceptional support to our clients an
Reference
JR129906
Expiry date
01/01/0001
Author
Sunidhi SinhaAuthor
Sunidhi SinhaSalary
Location
Brazil
Department
Clinical Operations Roles
Location
Brazil
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
2025-116323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Bangalore
Department
Clinical Operations Roles
Location
Bangalore
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
**Office-based; Bangalore location** We are currently seeking a Clinical Trial Assistant to join our diverse and dynamic team. As a Clinical Trial Assistant at ICON, you will play a pivotal role in as
Reference
2025-119066
Expiry date
01/01/0001
Author
Makarandha NargundAuthor
Makarandha Nargund