Associate Central Monitor - Data Surveillance, Clinical Data Sciences - Fsp

Parexel; Teletrabalho; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global biopharmaceutical services company in Brazil is seeking a professional to assist in implementing global strategies and manage data integrity for clinical trials. Responsibilities include setting up and testing risk-based monitoring analytics systems and ensuring compliance with regulatory standards. A bachelor's degree in a relevant field is required, along with strong communication and organizational skills. The role can be performed remotely, enhancing flexibility in work arrangements.

Qualificações

• Bachelor's degree or above of equivalent experience required.
• Ability to work independently and organize tasks.
• Strong communication skills with internal and external stakeholders.

Responsabilidades

• Assist the manager in implementing global strategies.
• Set up and test study level Risk-based Monitoring analytics system.
• Maintain quality control documentation for RBM activities.

Conhecimentos

Ability to organize tasks

Ability to communicate with stakeholders

Multi-tasking

Formação académica

Bachelor's degree or above in a scientific or business related discipline

Ferramentas

Oracle

PL/SQL

SAS

Java

Descrição da oferta de emprego

Job Summary

Role Responsibilities

General:

• Assist the manager implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
• Assist to set up and test study level Risk-based Monitoring analytics system using SAS/SQL/R/Python
• Help execute communication plans & methods to meet study requirement.
• Assist to resolve conflicts, influence and communicate with key stakeholders and customers.

System setup Functions:

• Set up and test RBM analytics system at study level to ensure system quality.
• Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
• Ensure RBM analytics system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data review Functions:

• Implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.
• Assist central monitoring activities including review system outputs, signal and action management.

Basic Qualifications:

• Bachelor's degree or above of equivalent experience in a scientific or business related discipline required.
• Works independently, receives instruction primarily on unusual situations
• Ability to organize tasks, time and priorities; ability to multi-task
• Ability to communicate with internal & external stakeholders, locally and globally

Preferred Qualifications:

• Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
• Technical expertise in supporting clinical trials database development, data management, site monitoring, etc.
• Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
• Familiar with the processes associated with clinical study management, data management, and regulatory operations.
• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

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