ICON plc

TMF Lead

ICON plc$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences, documentation management, or related field.
  • Experience in TMF management or clinical trial document management, ideally in healthcare or clinical research.
  • Understanding of regulatory requirements for TMF and clinical documentation.
  • Strong organizational skills with attention to detail to ensure compliance.
  • Effective communication and interpersonal skills for team collaboration.
  • Commitment to equity and inclusion in TMF management.
  • Willingness to travel up to 5%.

Responsibilities

  • Oversee trial master file (TMF) management processes to meet quality expectations.
  • Lead the establishment and maintenance of the TMF in compliance with regulations.
  • Collaborate with teams for accurate and timely TMF documentation.
  • Conduct quality checks and audits to resolve any TMF discrepancies.
  • Train and support team on TMF processes and best practices.
  • Implement continuous improvement strategies for TMF management.

Benefits

  • Comprehensive health and wellbeing programs including medical, dental, and vision coverage.
  • Retirement and pension plans offered.
  • Life assurance and disability coverage provided.
  • Access to employee assistance programmes and wellbeing resources.
  • Learning and development opportunities for professional growth.
Full Job Description
TMF Lead

As a Trial Master File (TMF) Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compliance with regulatory requirements and best practices in clinical trials.

What You Will Do:

You will oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:
  • Leading the setup, maintenance, and oversight of the TMF in compliance with regulatory standards and internal policies.
  • Collaborating with cross-functional teams to ensure timely and accurate documentation within the TMF.
  • Conducting regular TMF quality checks and audits to identify and resolve discrepancies or issues.
  • Providing training and support to team members on TMF processes and best practices.
  • Establishing and implementing strategies for continuous improvement in TMF management and documentation practices.


Your Profile:

You will have solid trial master file management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:
  • Bachelor's degree in life sciences, documentation management, or a related discipline
  • Proven experience in TMF management or clinical trial document management, preferably within the healthcare or clinical research industry.
  • Strong understanding of regulatory requirements and industry standards related to TMF and clinical documentation.
  • Excellent organizational skills and attention to detail, ensuring compliance and accuracy in TMF management.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
  • A commitment to promoting equity and inclusion in all aspects of TMF management.
  • Willingness to travel as required (approximately 5%)


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:
  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways


Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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