Expert Clinical Programmer

Novartis

Job Location:

Mumbai - India

Monthly Salary: Not Disclosed

Posted on: 13 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Responsible for configuring and managing the Central Monitoring Platform by translating study requirements into data-driven solutions while developing and maintaining Key Risk Indicators (KRIs) Quality Tolerance Limits (QTLs) and Data Quality Analytics/Statistical Monitoring tests to enable proactive risk detection. The role also involves building central monitoring dashboards and reports with accurate data ingestion harmonization and visualization for effective study oversight and acting as a technical cross-functional collaborator by working closely with Central Monitors study teams and stakeholders to ensure data quality and overall trial success.

Job Description

Key Responsibilities

Implement solutions for RBQM data review and cleaning as defined in data quality plans and enable the detection of data quality insights.
Manage configuration of system to support data ingestion transformation and provisioning required standard and study specific outputs ( e.g. KRIs QTLs ). Use SAS or Python programming skills while developing required outputs.
Troubleshoot and resolve routine technical issues related to build transformations reports and visualizations.
Support postproduction changes by performing impact analysis and helping implement approved change requests.
Participate in key study milestones such as database golives dry runs interim snapshots and database locks.
Support system upgrades and validations including impact assessments and execution of validation activities.
Develop and maintain study documentation ensuring accuracy completeness and compliance with standards.
Collaborate with internal teams and vendors act as subject matter expertise while continuously sharing knowledge within the team.

Essential Requirement

Minimum 6 years of experience in clinical review and report programming business analytics and/or clinical trial setup gained in the pharmaceutical industry CRO or Life Science related industry
Strong knowledge of any programming languages (SAS Python R etc.)
Knowledge of Data Review and/or Business Intelligence tools (such as Central monitoring platform)
Understanding of clinical data management systems and/or relational databases as applied to clinical trials
Ability to translate technical concepts for non- technical users in the areas of central monitoring platform design and visualization development
Strong verbal and written communication skills to work with our global partners and customers
Understanding of Drug Development Process ICH- GCP CDISC standards and Health Authority guidelines and regulations

Skills Desired

Clinical Trials Computer Programming Data Analysis Programming Languages Reporting Statistical Analysis

Required Experience:

Job Description SummaryResponsible for configuring and managing the Central Monitoring Platform by translating study requirements into data-driven solutions while developing and maintaining Key Risk Indicators (KRIs) Quality Tolerance Limits (QTLs) and Data Quality Analytics/Statistical Monitoring t...