摘要
-Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. -Complete oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within program/franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial. -Applicable to Clinical Scientific Expert Group Head:The CSE Group Head (CSE GH) supervises Clinical scientific experts (CSE I/ CSE II). Responsible for competency building of the team by coaching the Clinical Scientific Expert. The CSE GH facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands. Responsible for allocating/ balancing resources aligning with Clinical Development Functional Heads (CD-FH), Global Program Clinical Heads (GPCH), Therapeutic Areas Heads (TA Heads) and based on the Development Unit/portfolio needs.
About the Role
Major accountabilities:
- Responsible for the planning, executing and implementation of operational strategy of assigned clinical trial(s), -Develops materials for trial -related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations -Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other line function initiatives) -Contributes to talent and career development of associates through on -boarding, coaching, and/or mentoring support -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:
- Excellence in execution and implementation of clinical operations strategy -Timely, efficient and quality execution of assigned trial and trial related activities within budget, and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Cost effective management of budget and resources with limited unforeseen cost overruns.
- Applicable to Clinical Scientific Expert Group Head: -Strong leadership skills to be able to support management in team competency building, lead/contribute to local/global initiatives and best practice sharing across programs and/or departments -Efficient, quality-driven, timely delivery of quality documents to support Clinical Development activities by the team in compliance with international and local regulations and Novartis internal standards.
- Accountable for, review and updates resource needs for programs ensuring support to the portfolio.
- Timely delivery of program activities within the group to achieve critical milestones.
- Clearly anticipate and communicate risks.
- Cost effective management of budget and resource management within the CSE group.
- Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.
Minimum Requirements:
Work Experience:
- Organization Scope; Scale and Complexity.
- People Challenges.
- People Leadership.
Skills:
- Budget Management.
- Clinical Research.
- Clinical Trial Protocol.
- Clinical Trials.
- Coaching.
- Cross-Functional Teams.
- Data Analysis.
- Learning Design.
- Lifesciences.
- Risk Management.
- Risk Monitoring.
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