Clinical Data Analyst I and II

hace 1 mes


Medellín, Antioquia, Colombia Parexel A tiempo completo

About the Role

Parexel is seeking to hire multiple Clinical Data Analysts I and II to support our FSP team. These are remote roles, and we are open to candidates based anywhere in Argentina, Brazil, Mexico, and Colombia.

Key Responsibilities

The Clinical Data Analyst I will work under guidance and supervision to perform clinical data cleaning activities on assigned projects. Responsibilities will include support on data processing activities, data management documents, and data cleaning matrices. The Clinical Data Analyst II will perform all clinical data validation activities on assigned projects with minimal guidance and supervision. Responsibilities will include support on data validation activities, data management documents, and data cleaning matrices.

Key Accountabilities

Data Validation (cleaning)
Data Management Documents/Plans (Trial Master File)
Study Start-Up Activities and User Acceptance Testing (UAT)
Data Tracking and Entry
Project Quality Management & Compliance
Training

Requirements

Technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
Understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
Understanding of relevant ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures.
Knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase).
Understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
Experience in clinical research industry.
Basic knowledge of SAS (programmed listings).
Basic knowledge of Data standards (CDISC).
Advanced English level.

Education

Bachelor's degree and/or other medical qualifications or relevant industry experience.



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