Job Description

Summary -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.Clinical Scientific Expert, Group HeadLocation xe2x80x93 Hyderabad #LI HybridMajor 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.

Languages:

• English.

Why Novartis: Our purpose is to reimagine medicine to improve and extend peoplexe2x80x99s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYouxe2x80x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.Skills Desired 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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