Principal Clinical Programmer

Novartis

Job Location:

Mumbai - India

Monthly Salary: Not Disclosed

Posted on: 30+ 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:

RBQM Solution Development

Leads RBQM platform configuration develop specifications basis study documentation and inputs from study teams
Leads the configuration of system to support data ingestion transformation and provisioning required standard and study specific outputs ( e.g. KRIs QTLs )

Technical Support & Maintenance

Troubleshoot and resolve technical issues related to RBQM platform
Support the impact analysis and delivery of post-production change requests.
Identify quality issues & trends perform root cause analysis and recommend preventive actions.
Represent Clinical Dataflow & Insights team in key study milestones /discussions (database go-lives snapshots dry runs interim analysis DB locks).

People Project Engagement & Quality Management

Serve as a Subject Matter Expert (SME) for Clinical Dataflow & Insights providing expert guidance on best practices across studies and platforms.
Translate complex business needs into required solutions/ reports/ Visualizations.
Support Audits and Inspections.

Essential Requirements

Minimum 9 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

Classification Systems Clinical Trials Computer Data Storage Computer Programming Cross-Functional Teams Data Analysis Data Structures Initiative Programming Languages Reporting Statistical Analysis

Required Experience:

Staff IC

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...