388687BR
Apr 23, 2024
Mexico
About the Role
#Hybrid #CDMX
About the role:
Novartis Corporate Center Mexico City is one of six strategically located corporate centers established by Novartis globally. It brings together expert capabilities and talent across functionalities, that drives the business forward. It is home to 1000+ associates who work to deliver on the Novartis purpose of re imagining medicine to improve and extend people’s lives.
Your key responsibilities
• Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
• Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
• May identify new sites for clinical trials; analyze capability & make recommendation for trial inclusion. -Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
• Responsible for education, implementation & compliance to standards (SOPs) & best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
• Responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations etc.) executed by CONEXTS on behalf of Novartis Organizations, under the lead of Senior Clinical Project Manager (Sr. CPM) (where applicable).
• Work with the Sr. CPM (where applicable), Clinical Operations Specialist (COS) and Team leading the planning and implementation of all operational aspects of assigned clinical studies from concept to reporting/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). Responsible for ongoing and effective collaboration with customer, other Line Functions and third-party vendors. Track performance and quality aspect.
About the role:
Novartis Corporate Center Mexico City is one of six strategically located corporate centers established by Novartis globally. It brings together expert capabilities and talent across functionalities, that drives the business forward. It is home to 1000+ associates who work to deliver on the Novartis purpose of re imagining medicine to improve and extend people’s lives.
Your key responsibilities
• Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
• Conduct study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
• May identify new sites for clinical trials; analyze capability & make recommendation for trial inclusion. -Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
• Responsible for education, implementation & compliance to standards (SOPs) & best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
• Responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations etc.) executed by CONEXTS on behalf of Novartis Organizations, under the lead of Senior Clinical Project Manager (Sr. CPM) (where applicable).
• Work with the Sr. CPM (where applicable), Clinical Operations Specialist (COS) and Team leading the planning and implementation of all operational aspects of assigned clinical studies from concept to reporting/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). Responsible for ongoing and effective collaboration with customer, other Line Functions and third-party vendors. Track performance and quality aspect.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience
• + 8 years of Clinical Operations experience with managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization.
• Proven ability to work independently in a complex matrix environment.
• Good project management skills.
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
• Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
• Strong customer oriented mindset.
• Ability to resolve issues with minimal supervision and understand when to escalate.
• Willingness to act accountable in project
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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 achieve here at Novartis!
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
• + 8 years of Clinical Operations experience with managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization.
• Proven ability to work independently in a complex matrix environment.
• Good project management skills.
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
• Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills.
• Strong customer oriented mindset.
• Ability to resolve issues with minimal supervision and understand when to escalate.
• Willingness to act accountable in project
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, 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 achieve here at Novartis!
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
Global Business Solutions
Mexico
Ciudad de México
NOV CORPORATIVO MEX
Research & Development
Full Time
Regular
No
