Senior Clinical Data Scientist

1 week ago


Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

Provide professional and timely management of Data Management/Coding/CDDRA-Database Development/DAP deliverables and clinical trial data within Clinical Data Management.

Ensure high-quality data available for analysis and reporting.

Develop engaging and interactive training modules.

Utilize technology to simplify processes and training delivery.

Follow Good Clinical Practices (GCP) and data-handling procedures.

Review clinical research protocols, reports, and statistical analysis plans.

Manage data load, transfer, and conformance of Clinical trial data to NCDS compliant standards.

Contribute to the efficient execution of pharmaceutical drug-development plans.

About the Role

Major Accountabilities:

  • Provides Data Management leadership across assigned trials and acts as the Trial Data Manager when necessary.
  • Offers feedback to ensure well-written protocols and amendments.
  • Manages Data Handling plan and user acceptance testing (UAT).
  • Leads process and training deliverables within the platform or processes.
  • Ensures compliance with global regulatory requirements and business objectives.
  • Centralizes and aligns Data Operations for audits and inspections.
  • Coordinates exception requests, deviations, and corrective/preventative action plans.
  • Generates study status reports and provides support to Junior staff.
  • Performs accurate coding, troubleshoots coding problems, and leads dictionary version upgrade activities.
  • Acts as the primary study lead and technical consultant when needed.
Key Performance Indicators:
  • Achieve high quality, timeliness, cost efficiency, and customer satisfaction in Data Management activities.
  • Maintain adherence to Novartis policies and guidelines.
  • Receive feedback and satisfaction from customers, partners, and projects.
Minimum Requirements:
Work Experience:
  • Cross-Cultural Experience.
  • Project Management.
  • Functional Breadth.
Skills:
  • Statistical Programming.
  • Modeling & Simulation.
  • Biostatistics.
  • Trial Planning and Feasibility.
  • Clinical Trial Monitoring.
  • Regulatory Strategy.
  • And more.
Languages:
  • English.

Why Choose Novartis: Join a community of smart and passionate individuals dedicated to making a difference in patients' lives through innovative science and collaboration.

Join our Novartis Network: Stay connected and be informed about career opportunities by signing up for our talent community.

Division Operations

Business Unit Pharmaceuticals

Location Ireland

Site Dublin (Novartis Global Service Center)

Company/Legal Entity Novartis Ireland Ltd

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No

Novartis is committed to creating an outstanding and inclusive work environment.



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