ICON Clinical Research

TMF Lead

31 May 2021
30 Jun 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Trial Master File Lead

Based in Poland as an office employee in Warsaw.

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

If you have experience with electronic Trial Master File (eTMF) and a passion for learning and helping people, this might be a great fit for you!

The Trial Master File Lead:
  • Proactively manages the system and people to ensure study TMFs are Inspection Ready.
  • Monitors the health of the TMF and provides actionable analysis to improve completeness, quality and timeliness.
  • Serves as the eTMF Subject Matter Expert and primary Point of Contact for ICON and Sponsor study team members, listening to and collaborating with them to drive TMF success.
  • Actively identifies continuous improvement opportunities and enhances operational efficiency.

  • Bachelor's Degree
  • Minimum of 3 years TMF experience with at least 1 year of Veeva Vault eTMF experience or similar eTMF system
  • Knowledge of ALCOA+, Good Clinical Practice, Good Documentation Practice, International Council for Harmonization guidelines, and TMF Reference Model
  • Excellent organizational and negotiation skills, the ability to manage multiple tasks and exceptional attention to detail
  • Strong written and verbal communication skills to effectively work with global teams
  • Proficiency in Microsoft Outlook, PowerPoint and Excel

Why join us?
  • Ongoing development is vital to us, and as a TMF Lead you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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.

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