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Associate Central Monitor - Data Surveillance, Clinical Data Sciences - Fsp
Parexel
Remote
BRL 80,000 - 120,000
Full time
3 days ago
Be an early applicant
Job summary
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.
Qualifications
- Bachelor's degree or above of equivalent experience required.
- Ability to work independently and organize tasks.
- Strong communication skills with internal and external stakeholders.
Responsibilities
- 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.
Skills
Ability to organize tasks
Ability to communicate with stakeholders
Multi-tasking
Education
Bachelor's degree or above in a scientific or business related discipline
Tools
Oracle
PL/SQL
SAS
Java
Job description
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.
LI-REMOTE
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.