100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as SSO Clinical Project Manager! #GCO
Location: Open to Shanghai/Beijing/Guangzhou/Chengdu/Wuhan City
Job Purpose:
The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.
The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
Your responsibilities include, but are not limited to:
3.Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations. Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies
4.Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues. Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary. Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
6.Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation. Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times. Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
7.Provides feedback about the quality of monitoring activities to CRA Managers, MSOM, SSO Country Managers, FSP/BiS line managers (as propriate) and local QA (when required per Novartis SOPs). Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with country Portfolio Execution and Quality Assurance for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines. Participates in multidisciplinary taskforces to support continuous improvement initiatives
Location: Open to Shanghai/Beijing/Guangzhou/Chengdu/Wuhan City
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Job Purpose:
The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.
The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
Your responsibilities include, but are not limited to:
- Study & Site Operations strategy
- Initiation and conduct of trials
3.Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations. Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies
4.Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues. Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary. Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
- Delivery of quality data and compliance to quality standards
6.Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation. Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times. Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
7.Provides feedback about the quality of monitoring activities to CRA Managers, MSOM, SSO Country Managers, FSP/BiS line managers (as propriate) and local QA (when required per Novartis SOPs). Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with country Portfolio Execution and Quality Assurance for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines. Participates in multidisciplinary taskforces to support continuous improvement initiatives
- Budget and productivity
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Minimum requirements
What you’ll bring to the role:
Required Experience & Qualifications:
1.A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English
2.Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
3.Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries. Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
5.Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
6.Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
7.Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
8.Communicates effectively in a local/global matrixed environment
#GCO
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
无障碍及便利设施
诺华承诺与残障人士共事并为他们提供合理的便利设施。如果您由于健康状况或残障，在招聘过程的任何环节需要合理便利设施，或者为了履行职位的基本职能，请发送电子邮件至 diversityandincl.china@novartis.com，告知您的需求和联系方式，并在邮件中附上您的职位申请编号。
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
Required Experience & Qualifications:
1.A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English
2.Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
3.Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries. Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
5.Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
6.Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
7.Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
8.Communicates effectively in a local/global matrixed environment
#GCO
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
无障碍及便利设施
诺华承诺与残障人士共事并为他们提供合理的便利设施。如果您由于健康状况或残障，在招聘过程的任何环节需要合理便利设施，或者为了履行职位的基本职能，请发送电子邮件至 diversityandincl.china@novartis.com，告知您的需求和联系方式，并在邮件中附上您的职位申请编号。
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
Division
Global Drug Development
Business Unit
GCO GDD
Country
China
Work Location
Shanghai
Company/Legal Entity
CNIBR Co. Ltd.
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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