摘要
-Responsible for all statistical programming/data review reporting & Analytics development aspects of one or more drug development projects or disease area. Direct, oversee and coordinate all activities, deliverables and resources within respective group or disease area. Ensure trials are conducted to a consistently high standard with respect to cost, quality and timelines.
About the Role
Major accountabilities:
Acts as a key functional expert who manages, directs and coordinates the activities of a specific assigned area, project or team of experienced specialists -Determines methods and procedures on new projects/ assignments. Leads the decision‐making process for establishing multidisciplinary project/program goals within own team -Defines team goals, aligns and provides input to department strategy -Manages and coordinates the assignment of resources and workload within his/her group or disease area, and ensures sharing of resources between groups in order to meet departmental objectives and priorities. May act as a subject Matter Expert for key operational areas influencing respective function . Provides all necessary support to help address and resolve issues. Identifies solutions for remediation -Understands Health Authority requirements and is able to participate in Health Authority inspections as required -Leads and supports clinical and non-clinical special projects and initiatives -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators:
Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables. Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction Minimum Requirements: Work Experience:
Clinical Research Phases. Biostatistics. R&D Portfolio Management. Regulatory Submissions. Innovative & Analytical Technologies. Data Management & Systems. Statistical Programming. Clinical Trial Design, Data Review & Reporting. Skills:
Classification Systems. Clinical Trials. Computer Data Storage. Computer Programming. Cross-Functional Teams. Data Analysis. Data Structures. Initiative. People Management. Programming Languages. Project Management. Reporting. Statistical Analysis. Languages :
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Business Unit
Innovative Medicines
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
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