389235BR
Apr 22, 2024
India
About the Role
Clinical Project Manager
Location – Hyderabad #LI Hybrid
About the Role:
This role is responsible to Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.
Key Responsibilities:
• Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved or support the Sr. CPM (where applicable).
• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.
• Might be required to support or lead other projects/program, in collaboration with cross-functional teams.`
• Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
• As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement.
• As applicable, support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required.
• Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
• As applicable, responsible for review of all site visit related reports and quality control of monitoring activities in timely manner.
Location – Hyderabad #LI Hybrid
About the Role:
This role is responsible to Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.
Key Responsibilities:
• Agree with colleague/customer team and Line Functions on realistic project and study timelines. Escalate to higher level in the organization if no agreement can be achieved or support the Sr. CPM (where applicable).
• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP//Research Collaborations/IIT/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures.
• Might be required to support or lead other projects/program, in collaboration with cross-functional teams.`
• Responsible for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
• As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard with local regulation requirement.
• As applicable, support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required.
• Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
• As applicable, responsible for review of all site visit related reports and quality control of monitoring activities in timely manner.
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
Essential Requirements
• Approximately 8 years’ of Global Clinical Operations experience with managerial experience in designing, 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 (including remote), including leading cross-functional team.
Desirable Requirements:
• Solid 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 accountably in project/study management.
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 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-culture
You’ll 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-rewards
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.
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.
• Approximately 8 years’ of Global Clinical Operations experience with managerial experience in designing, 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 (including remote), including leading cross-functional team.
Desirable Requirements:
• Solid 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 accountably in project/study management.
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 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-culture
You’ll 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-rewards
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.
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
India
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
