24 hours ago
Mumbai, India or Hyderābād, IndiaStaff+
Responsibilities
- Lead central monitoring platform configuration across an assigned portfolio of clinical studies.
- Design and maintain Key Risk Indicators, Quality Tolerance Limits, risk signals, statistical monitoring models, and related libraries.
- Draft platform specifications using clinical protocols, CRFs, study ALS documents, and vendor data-transfer specifications.
- Deliver end-to-end platform configuration, validation, user acceptance testing, study go-live, refreshes, change requests, amendments, troubleshooting, and archival activities.
- Resolve complex data integration, transformation, visualization, platform, and risk-signal generation issues.
- Partner with clinical, central monitoring, data management, biostatistics, technology, vendors, and other stakeholders.
- Advance automation, artificial intelligence, machine learning, and statistical approaches for risk detection.
- Provide technical guidance, training, coaching, and knowledge sharing to team members and stakeholders.
- Drive AI, automation, and future-state analytics strategy while scaling capabilities across the clinical portfolio.
- Define success measures and drive team objectives.
Requirements
- More than 12–14 years of relevant experience in pharmaceutical development, clinical research, data analytics, or healthcare technology.
- Strong experience delivering Risk-Based Quality Management and Central Monitoring solutions across clinical trial portfolios.
- Hands-on experience configuring central monitoring platforms, analytics modules, dashboards, and reporting solutions.
- Experience developing Key Risk Indicators, Quality Tolerance Limits, risk signals, and statistical monitoring models.
- Strong knowledge of clinical data integration, ingestion, harmonization, mapping, transformation, visualization, validation, and analytical troubleshooting.
- Knowledge of International Council for Harmonization E6(R3), risk-based monitoring principles, and clinical trial quality management.
- Ability to interpret protocols, monitoring plans, quality plans, critical data, endpoints, critical-to-quality factors, risks, and study-specific needs.
- Experience working with data from EDC, CTMS, IRT/IWRS, laboratory, and other third-party sources.
- Experience using SAS, SQL, R, Python, or equivalent languages for data manipulation, analytics, automation, and troubleshooting.
- Strong leadership, communication, stakeholder-management, and global matrix collaboration skills.
- Desirable experience implementing artificial intelligence, machine learning, automation, or advanced statistical monitoring solutions.
- Desirable advanced knowledge of unsupervised statistical testing and approaches for improving signal quality and reducing false positives.
- Experience leading technical delivery across a portfolio of global clinical studies and coaching junior colleagues and cross-functional stakeholders.
Benefits
- Hybrid working arrangement.
- Primary location in Hyderabad, India, with Mumbai, India also listed as a location.
- Relocation support is available.
- Novartis provides personal and professional development benefits and rewards.
About Novartis
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki