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Apply to JobJob ID249985BRPosition TitleExpert Global Trial ManagerJob DescriptionAs Expert Global Trial Manager you will contribute, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. You may lead specific aspects of global clinical trial(s).

You are a core member of the Clinical Trial Team, deputy for the (Associate) Global Trial Director, and contribute to operational excellence through process improvement and knowledge sharing.



Accountabilities:

1. Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to :

• Development of specific sections of the protocol and related documents;

• Development of study tools, guidelines and training materials;

• Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee);

• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);

• Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders;

• Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts;

• Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;

• Contributing to the creation and execution of an operational risk management plan, highlighting potential risks and actions;

• Implementing issue resolution plans;

• Acting as point of contact for all site-related issues and procedural questions;

• Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations;

• 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.



2. Resource Management:

Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl forecast, and annual cost targets.



3. Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes; can deputize for the (Associate) Global Trial Director to chair and facilitate CTT meetings. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).



4. As member of the CTT, contribute to defining the data review plan; participate in data review as specified in the Data Review Plan.



5. Contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups.



6. Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.Minimum requirements• Advanced degree or equivalent education/degree in life science/healthcare recommended.

• 3-5 years of experience in clinical development with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.

• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.

• Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.

• Proven networking skills and ability to share knowledge and experience amongst colleagues.

• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.

• Basic knowledge of appropriate therapeutic area.

• Fluent English (oral and written).



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 this: 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’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re 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.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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