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CDC II

  1. Mexico
2023-101435
  1. Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
  2. ICON Strategic Solutions
  3. Remote

About the role

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As a Clinical Data Coordinator you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.

 

You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks including writing ADaM specifications, programing ADaM datasets, programming efficacy outputs, and submission work.

 


What you will be doing:

 

Supports and executes the data review activities, including data validation and analytics, that contribute to delivery of clinical data that meets agreed upon data integrity standards.

 

• Supports activities related to development of the clinical data management systems (CDMS), as needed.
• Supports and executes the data review activities, including data validation and analytics, associated with a clinical trial to ensure the end product of clinical data meets agreed upon data integrity standards.
• Detects risks and signals in the data using quality indicators.
• Performs root cause analysis of detected data issues.
• Reviews clinical and third party data for subjects enrolled in clinical research protocols based on edit specifications/ Integrated data review plan to facilitate data review.
• Maintains clinical data management related study documentation as appropriate.
• Manages third party data reconciliation and data review process.
• Ensures study and task metrics are tracked and communicated to the clinical data scientist, project team and functional management.
• Responsible for review of standard quality indicator review including root cause analysis for identification of underlying


What you need:

 

• Bachelor’s degree in Science or Health
• 1 year of relevant experience
• Advanced English

 

Why ICON?

 

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

 

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, colour, 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.

 

 

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

 

 

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