About the role

Aplyr's Quick Take

This role is about managing and configuring a Central Monitoring Platform for clinical trials, focusing on data quality and risk detection. You'll be programming in SAS or Python, building dashboards, and collaborating with various teams to ensure data integrity throughout the trial process. It's primarily an individual contributor role with some technical collaboration.

Good fit

Ideal candidates have at least 6 years of experience in clinical programming or analytics, preferably in the pharmaceutical or life sciences sectors. Strong programming skills and the ability to communicate technical concepts clearly are essential.

Worth noting

The role involves significant technical troubleshooting and collaboration with global teams, which may appeal to those who enjoy problem-solving in a dynamic environment. The emphasis on data quality and risk management suggests a critical role in ensuring trial success.

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 post‑production changes by performing impact analysis and helping implement approved change requests.
Participate in key study milestones such as database go‑lives, 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

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.