Principal Clinical Programmer

Job Description

^4 The number of projects that you would lead or support across multiple therapeutic areas.
We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation, Reporting & Analytics & provisioning of data to downstream applications & teams.

Your responsibilities include, but are not limited to:

•Lead functional activities for a medium to large sized project in phase I to IV clinical
studies in Novartis Global Development Organization.Co-ordinate activities of Data Managers either internally or externally. Make data Mgmt decisions and propose strategies at study or project level.

•Ensure application of consistent data Mgmt processes, influence increased standardization
and documentation across assigned project/programs.Comply with company, department and industry standards and processes. Provide and implement data Mgmt solutions; ensure knowledge sharing.

•Leads process and training deliverables within multiple platforms, franchises or
therapeutic areas Develops strategies to ensure effective training and knowledge retention. Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting). Drives towards agreed
deliverables, proactively addressing potential issues before they become problematic.

•Build and maintain effective working relationship with cross-functional teams, able to
summarize and discuss status of deliverables and critical data Mgmt aspects.Represents DO in all audits and inspections, centralizing and aligning the team in audit
preparation, readiness and response.

•Manages and measures quality -Coordinates exception requests, deviations and corrective/preventative action plans Ensure timely and quality development/ validation of CRFs and edit specifications for assigned studies/programs Responsible for quality control and audit readiness of all assigned data Mgmt deliverables as well as accuracy and reliability of the clinical database.

•Coaches & mentors associates as required. Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives. Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects. Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions . Represent Data Mgmt at audits & in Health Authority (HA) meetings for assigned project(s).

•Provide Functional/technical Coding leadership for Therapeutic Area/Franchisee having multiple trials or mega trials in the role of Lead Coder ans ensures that Clinical Coding is performed at a consistently high standard. Serves as the primary program/therapeutic area ead ensuring timely & quality deliverables.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What You’ll bring to the role:

• Clinical Trial Set-up, Management & Conduct
• Compound to the Clinic - Preclinical and Translational Medicine
• Modeling & Simulation
• Over The Counter Product Development
• Post Authorization Data Safety
• Regulatory Strategy
• Statistical Programming
• Trial Planning and Feasibility

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network