Overview
We are seeking a Senior Principal Clinical Data Scientist responsible and accountable for managing all Data Management / Coding / CDD / DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard.
This position is a senior key collaborator and strategic partner with stakeholders, ensuring that pharmaceutical drug development plans in Novartis Development are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees Good Clinical Practices (GCP), data-handling procedures and guidelines. Ensuring consistency across assigned program to aid efficiencies for submissions, and participates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables.
Major accountabilities
* Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
* Coordinate activities of Data Managers either internally or externally.
* Make data management decisions and propose strategies at study or project level.
* Ensure application of consistent data management processes; influence increased standardization and documentation across assigned projects/programs; comply with company, department and industry standards and processes.
* Provide and implement data management solutions; ensure knowledge sharing.
* Lead process and training deliverables within multiple platforms, franchises or therapeutic areas. Develop strategies to ensure effective training and knowledge retention.
* Progress toward complete, compliant, agile and simple end-to-end processes and effective training (Protocol/Measure through Analysis and Reporting).
* Drive toward agreed deliverables, proactively addressing potential issues before they become problematic. Build and maintain effective working relationships with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects.
* Represent Data Operations in audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.
* Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives.
* Develop risk management strategies to prevent data quality/coding issues from derailing projects; report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples (where applicable).
Minimum Requirements
* Degree or Masters qualification in a relevant area.
* Ideally 9+ years’ experience in Drug Development with at least 8 years' in Clinical Data Management.
* Experience working across several end-to-end studies.
* Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines.
* A background of coaching and mentoring team members as required, ensuring that data management associates on the individual programs are aware of risks, priorities, goals and impact of the work contribution.
* Excellent understanding of clinical trials methodology, GCP and medical terminology.
* Proven ability to interrogate and view data through various programming/GUI techniques.
Commitment to Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis
Joining Novartis means contributing to breakthroughs that change patients’ lives. If this specific role isn’t right for you, consider joining our talent community to stay connected for future opportunities.
Job details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
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Location: Dublin, Ireland
Posted: 2 weeks ago
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