Senior Clinical Data Lead

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Descripción del trabajo - Senior Clinical Data Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

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.

We have an incredible opportunity for a Senior Clinical Data Lead to join ICON’s Medical Imaging team.

LOCATION: Mexico City (office-based with remote flexibility)

OVERVIEW OF THE ROLE:

The Senior Clinical Data Lead is responsible for generating deliverables and datasets per sponsor requirements. The Senior CDL will also write data transfer specifications in collaboration with the client. This individual will work in the medical imaging team and utilize proprietary systems.

  • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Read, ensure understanding and adhere to all assigned ICON/Client SOPs and working procedures.
  • Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
  • Contribute to the development of specifications, implementation, and testing for the eCRF or paper CRF.
  • Participate in the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
  • Lead development of the data management plan and study specific procedures.
  • Lead development of specifications for custom reporting on the study.
  • Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.

TO BE SUCCESSFUL, YOU WILL NEED:

  • 4+ years of data management experience (in a Clinical Research Organization or Pharmaceutical company)
  • Experience working with databases to extract and format data
  • Highly computer literate
  • Excellent organizational skills as well as attention to detail
  • Ability to prioritize competing or shifting deadlines
  • Ability to read, write, and speak fluent English
  • Bachelor’s degree or local equivalent in a scientific, healthcare, math, or technology field and/or appropriate experience
  • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language.

* Please submit all applications in English *


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.

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