Senior Principal Clinical Data Scientist

Job Description Summary

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 & 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 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 areasDevelops 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.

• 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.

• A background of coaching and mentoring team members as required, ensuring that data management associates on the individual programs are aware of the 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.

 

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