Senior TMF Lead

Employer
ICON - EMEA
Location
Poland
Salary
Competitive
Start date
15 Nov 2022
Closing date
15 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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 center 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.

If you have an extensive experience interpreting clinical trial protocols for the purpose of establishing and designing the documentation requirements within Trial Master File system, learn more about how you can be a part of ICON’sTrial Master File Operationsgroup that’s responsible for verifying clinical trial documentation is consistent with the TMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.

About the Senior Trial Master FileLead role within ICON:
  • TheSenior Trial Master FileLeadwill play a key role in developing and assisting with the implementation of TMF specifications, ensuring they are in alignment with the program strategy and milestones.
  • Assess the impact of potential changes to TMF specifications prior to implementation and collaborate with Sponsor Teams as appropriate. Serve as the single point of contact forfunctional team members and clientsrelated to TMF processes and activities.
  • Under the supervision of the TMF OperationsLeadership team, the Trial Master File Owner/Lead will assist with responses to regulatory authorities /inspectors with regard to documentation management activities for audits, questions, and issues.
  • The Senior Trial Master File Lead will regularly review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and across programs, and assist with the development of corrective action plans related to TMF findings.
  • The Senior Trial Master File Lead will review the processes to actively identify continuous improvement opportunities and enhance operational efficiency. Working in a professional and employee friendly environment, the TMF Lead will frequently communicate within both internal and external clients in a professional manner.


To succeed you will need:
  • Bachelor’s Degree is required along with a minimum of 7+ years of Clinical Operations/Documentation Management/Clinical Research industry experience .
  • You will require TMF and industry experience to understand the processes and documents required within the conduct of clinical trials.
  • You will have good organizational and negotiation skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
  • You will possess good written and verbal communication skills with global projects/team exposure. Project Management and Quality Assurance experience will be an added advantage
  • Competent computer skills - MS Outlook, PPT, Excel and experience with electronic document management systems preferred.”


Benefits of Working in ICON:

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.

At 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.

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, 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.

Company

We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

Find Us
Telephone
01628 496300
Location
3rd Floor
Marlow International
Marlow
Buckinghamshire
SL7 1YL
United Kingdom
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