Senior Clinical Data Coordinator

hace 2 semanas

Bogota, Colombia ICON A tiempo completo

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 Coordinator** to join the team.

**Location**: home-based OR office-based
- Mexico
- Colombia

**Overview of the Role**:
As a Senior Clinical Data Coordinator at ICON, you will work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified Clinical Data Managers to identify, select, initiate and closeout investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
- Review CRF / eCRF data for completeness, accuracy, and consistency via computerize edits and manual data checks
- Perform external data reconciliation and SAE reconciliation
- Generate and close/resolve data queries
- Freeze and/or lock eCRFs within the Electronic Data Capture System
- Create and maintain study files and other appropriate study documentation
- Perform User Acceptance Testing (UAT) and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
- Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures
- Train and guide less experienced CDCs in data management requirements and activities
- Minimum travel may be required (less than 5%)

**To be successful you will need**:

- 2+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company) performing activities such as data reconcilation, reviewing eCRFs, UAT, etc.
- Excellent written and oral communication skills
- Excellent accuracy and attentiveness to detail
- Knowledge of database technologies and processes
- Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct
- Bachelor’s degree or local equivalent in a scientific field and/or appropriate experience

**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.**

**#LI-Remote

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