Job Description Summary
We are seeking a 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 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 & guidelines. Ensuring consistency across assigned program to aid efficiencies for submissions as well as 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.
Job Description
Major accountabilities:
- 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 management decisions and propose strategies at study or project level.
- Ensure application of consistent data management processes, influence increased standardization and documentation across assigned project/programs -Comply with company, department and industry standards and processes.
- Provide and implement data Management 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 towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting).
- Representative in all 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.
- Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects -Reporting of 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 / Masters qualified 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
- 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.
Skills Desired
Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model