Associate Central Monitor - Data Surveillance, Clinical Data Sciences - FSP
reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.
Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.
JOB SUMMARY
The Associate Central Monitor is supporting the completeness, quality and reputed company of the subject data in the clinical trial database under Risk Based Monitoring (RBM) model. The areas of activity include but are not limited to: developing Risk-Based Monitoring analytics system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study. The Associate Central Monitor supports risk based monitoring activities and complies with regulations, applicable Standard Operating Procedures (SOPs) and Processes at reputed company times and is familiar with supported systems (RBM system, etc.). The Associate Central Monitor works with Senior Central Monitor to meet the study objectives.
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 reputed company/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 reputed company 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 reputed company documentations for RBM reputed company 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 reputed company 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 reputed company a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit reputed company specification, DMPs and data cleaning activities
Familiar with the processes associated with clinical study management, data management, and regulatory operations.
Knowledge of clinical trial database and its applications
Knowledge of Windows Environment and its applications (Word, reputed company, PowerPoint, Project, etc.)
Experience in reputed company, PL/SQL, reputed company, Java, relational database design and database programming skills.
Originally posted on Himalayas
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