Principal Clinical Data Scientist

2 weeks ago

Dublin, Ireland Novartis Farmac?Utica Full time

Overview
We are seeking a
Principal Clinical Data Scientist
responsible for managing all Data Management, Coding, CDD, and DAP aspects of multiple studies, ensuring high standards across medium to large projects.
This role involves collaborating with stakeholders to execute pharmaceutical drug development plans efficiently, delivering high-quality and timely results.
The candidate will conceptualize and implement scalable training models for end-to-end deliverables, oversee GCP and data-handling procedures, and ensure consistency across programs to facilitate submissions.
Participation in protocol, report, and statistical analysis plan reviews is expected, along with leading quality deliverables and developing strategies for quality assurance.
Major accountabilities
Lead functional activities for medium to large projects in phase I to IV clinical studies within Novartis Global Development.
Coordinate activities of Data Managers internally and externally.
Make data management decisions and propose strategies at study or project levels.
Ensure application of consistent data management processes, promote standardization, and ensure compliance with industry standards.
Implement data management solutions and facilitate knowledge sharing.
Lead process and training initiatives across multiple platforms and therapeutic areas, developing effective training strategies.
Advance towards complete, compliant, and efficient end-to-end processes with effective training from protocol development to reporting.
Represent the team in audits and inspections, preparing and responding to audit requirements.
Act as SME or lead process improvement initiatives as assigned.
Develop risk management strategies to prevent data quality issues and report technical complaints or adverse events within 24 hours.
Manage distribution of marketing samples where applicable.
Qualifications
Degree or Master's in a relevant field.
Ideally 9+ years' experience in Drug Development, with at least 8 years in Clinical Data Management.
Experience across several end-to-end studies.
Strong leadership, collaboration, and organizational skills with proven ability to manage multiple trials and meet deadlines.
Excellent understanding of clinical trial methodology, GCP, and medical terminology.
Proven ability to analyze data using programming or GUI techniques.
Commitment to Diversity & Inclusion
We are dedicated to building an inclusive work environment and diverse teams that reflect the patients and communities we serve.
Why Novartis:
Join us to help change patients' lives through innovative science and a passionate community.
Learn more at Novartis Careers.
Join our Novartis Network:
Stay connected and learn about new opportunities by signing up at Talent Network.
IE02 (FCRS = IE002) Novartis Ireland Ltd
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