Regional Head, Monitoring Excellence
NovartisShanghaiUpdate time: September 16,2019
Job Description
Your responsibilities:
Your responsibilities include, but not limited to:
1. Leads team of regional Process Control Managers (rPCMs) and regional Training Managers to develop functional center of excellence within the assigned region by identifying and implementing best-in-industry practices.
2. Leads the regional group of regional PCMs to drive quality in the region, countries, and sites through risk management, design of programs to improve quality systems and standards, monitoring process, and develop corrective and/or preventive actions, in collaboration with TMO regional heads and the Process Control Global Head.
3. Establishes and implements regional strategies and objectives with the goal to increase and sustain a high performance and quality in Trial Monitoring within the assigned region, in collaboration with Trial Monitoring Region and Countries, other GDO functions, and Quality Assurance (QA) partners.
4. Represents TMO in inspections and audits, coordinates activities for preparation, supports during inspections, and follows-up on actions and commitments within the assigned region.
5. Leads multi-functional teams within TMO as appropriate to develop and implement multi-disciplinary process & quality improvement solutions/initiatives in Trial Monitoring. In collaboration with the global monitoring excellence team, the Process Control Global Head, and key stakeholders.
6. Ensures consistency, efficiency, and high level of compliance within the assigned region.
7. Is responsible for the oversight and facilitation of quality and process improvement, and for implementing quality control within the TMO function within the assigned region through oversight of Key Quality Indicators (KQIs) and other tools, driving self-inspection activities and providing overall support to Trial Monitoring associates in countries and the region in collaboration with the Process Control Global Head and the Global Head Training.
8. Addresses potential quality issues and emerging compliance concerns, and recommends solutions within the assigned region in collaboration with the QA partners.
9. Develops relevant remedial and improvement actions for Corrective Action Plans from audits and is responsible for follow-up on completion and implementation of relevant tasks within the assigned region.
10. Leads the regional group of regional Training Managers to create, design and implement capability building strategy for TMO within the assigned region in collaboration with the Global Head Training.
Your responsibilities include, but not limited to:
1. Leads team of regional Process Control Managers (rPCMs) and regional Training Managers to develop functional center of excellence within the assigned region by identifying and implementing best-in-industry practices.
2. Leads the regional group of regional PCMs to drive quality in the region, countries, and sites through risk management, design of programs to improve quality systems and standards, monitoring process, and develop corrective and/or preventive actions, in collaboration with TMO regional heads and the Process Control Global Head.
3. Establishes and implements regional strategies and objectives with the goal to increase and sustain a high performance and quality in Trial Monitoring within the assigned region, in collaboration with Trial Monitoring Region and Countries, other GDO functions, and Quality Assurance (QA) partners.
4. Represents TMO in inspections and audits, coordinates activities for preparation, supports during inspections, and follows-up on actions and commitments within the assigned region.
5. Leads multi-functional teams within TMO as appropriate to develop and implement multi-disciplinary process & quality improvement solutions/initiatives in Trial Monitoring. In collaboration with the global monitoring excellence team, the Process Control Global Head, and key stakeholders.
6. Ensures consistency, efficiency, and high level of compliance within the assigned region.
7. Is responsible for the oversight and facilitation of quality and process improvement, and for implementing quality control within the TMO function within the assigned region through oversight of Key Quality Indicators (KQIs) and other tools, driving self-inspection activities and providing overall support to Trial Monitoring associates in countries and the region in collaboration with the Process Control Global Head and the Global Head Training.
8. Addresses potential quality issues and emerging compliance concerns, and recommends solutions within the assigned region in collaboration with the QA partners.
9. Develops relevant remedial and improvement actions for Corrective Action Plans from audits and is responsible for follow-up on completion and implementation of relevant tasks within the assigned region.
10. Leads the regional group of regional Training Managers to create, design and implement capability building strategy for TMO within the assigned region in collaboration with the Global Head Training.
Minimum requirements
What you’ll bring to the role:
1. Advanced Degree or equivalent education/degree in life science/healthcare required (PhD/MD Preferred). Fluent in both written and spoken English. Additional language, if used for local Business purposes.
2. 10 years of pharmaceutical clinical drug development experience, in planning/executing and/or monitoring clinical trials.
3. 5 years people management incl. leadership of managers and talent development experience required, this may include management in a matrix environment. People management with responsibility for internal resource estimation /allocation required.
4. Demonstrated leadership and accomplishment in all aspects of conducting or supporting clinical trials and pro-grams with cross-functional teams.
5. Strong management, interpersonal, problem solving, negotiation, and conflict resolution skills.
6. Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), regulatory requirements from health authorities (FDA/EMEA), local/National. Novartis experience in these areas is preferred.
7. Proven track record in clinical operations process improvements. Monitoring experience is preferred
Why consider Novartis?
750 million.
That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where, you are entitled the opportunities to explore the power of digital and data. Where, you are empowered to risk failure by taking smart risks, and where, you are surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
1. Advanced Degree or equivalent education/degree in life science/healthcare required (PhD/MD Preferred). Fluent in both written and spoken English. Additional language, if used for local Business purposes.
2. 10 years of pharmaceutical clinical drug development experience, in planning/executing and/or monitoring clinical trials.
3. 5 years people management incl. leadership of managers and talent development experience required, this may include management in a matrix environment. People management with responsibility for internal resource estimation /allocation required.
4. Demonstrated leadership and accomplishment in all aspects of conducting or supporting clinical trials and pro-grams with cross-functional teams.
5. Strong management, interpersonal, problem solving, negotiation, and conflict resolution skills.
6. Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), regulatory requirements from health authorities (FDA/EMEA), local/National. Novartis experience in these areas is preferred.
7. Proven track record in clinical operations process improvements. Monitoring experience is preferred
Why consider Novartis?
750 million.
That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where, you are entitled the opportunities to explore the power of digital and data. Where, you are empowered to risk failure by taking smart risks, and where, you are surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Division
Global Drug Development
Business Unit
GDO GDD
Country
China
Work Location
Shanghai
Company/Legal Entity
CNIBR Co. Ltd.
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
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