Location
Andhra Pradesh | India
Job description
About the role
Operational Health Lead.
Location – Hyderabad
About the Role:
Operational Health Lead will be responsible to define and maintain the Clinical Data Operations (CDO) key metrics and key performance indicators (KPI) to enable the organization to oversee key objectives and performance and drive process improvement initiatives. This role is responsible to drive the collaboration between Business/Line functions and other teams, stakeholders to define a metrics program that is fit for purpose, value added and considered an essential management tool for identifying and mitigating risk and for continuous process and quality system improvement. Manage the automation of data collection for reporting, gather and review high quality and meaningful commentary and provide dashboards and regular management update reports to GCO functions. Lead the development of innovative solutions for effective tracking, management and oversight of key governance and training compliance data.
Key Responsibilities:
Metrics Management
•Leads collection and analysis of CDO metrics. Develops strategies to ensure effective metrics management within CDO.
•Collaborates cross functionally to ensure appropriate awareness of metrics and initiatives pertaining to CDO metrics are communicated.
•Accountable for all aspects of the metrics within remit to ensure full compliance to timelines and quality of metrics data/analysis.Drives CDO metrics towards agreed deliverables, proactively addressing potential issues before they become problematic
•Build and maintain strong partnerships within GCO and CDO. Represents DO for metrics related initiatives and acts as a cross functional representative where assigned.
•Leads independently or participates in metrics improvement initiatives and/or non-clinical projects.
iDOT Tools Management
•Adept and working knowledge of different Project management models, creating project plan, Raci metrics, implementation of projects and regular tracking. Practical knowledge of risk identification and mitigation in project management.
•Liaising with the concerned stakeholders regarding project requirements. Contributing, outlining, defining, and initiating the project plan. Implementing document control policies and documentation templates. Flexible to work in different project roles as need arises.
Maintaining a good working knowledge of assigned component projects. Working with the functional spocs for evaluating standards of component products.
•Monitoring project progress and working with the functional SPOCs and the development team to make changes to the project plan where necessary. Compiling project reports and informing management regarding problems. Ensuring project complies with best practices, SOPs, PMO policies, and other policies.
Role Requirements
Essential Requirements:
•Bachelor’s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred post-graduate university or college degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent.
•Good in metrics management and data analysis. Significant relevant experience and knowledge in the Pharmaceutical or Device Industry.
•Expert in regard to process development and training implementation. Lean Six Sigma certification preferred.
•Advanced knowledge in regard to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH).
•At least 7 years of experience in global drug development, within the pharmaceutical or device industry.
Desirable Requirement:
•A demonstrated expert in Data Management and Statistical Programming, providing guidance, mentoring and support to Process and Training Leads.
•Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
•Outstanding verbal and written skills.
•Proven ability to proactively identify issues, recommend and implement solutions.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our
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Commitment 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.
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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.
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