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 management. You'll work closely with study teams to develop solutions and troubleshoot issues, acting as a technical expert in a collaborative environment. It's primarily an individual contributor role with a strong emphasis on programming and analytics.

Good fit

Ideal candidates have at least 9 years of experience in clinical programming or analytics within the pharmaceutical or life sciences sectors. A solid background in programming languages and data management is essential, along with strong communication skills for cross-functional collaboration.

Worth noting

The position requires a high level of technical expertise and involves significant responsibility for data quality oversight. The role may also include interactions with global partners, which could be a plus for those looking to work in an international context.

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

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.