Global Trial Manager - Novartis dedicated

Supports operational and some scientific aspects of global clinical trial(s), under the management of the (Associate) Global Trial Director. Core member of the Clinical Trial Team.

Responsibilities:

Supports the (Associate) Global Trial Director to ensure all trial deliverables are met 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;
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
• Supporting the development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); supporting 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;
• Implementing issue resolution plans;
• Supporting management of 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.

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. Extended member of the Global Clinical Team (GCT).

Participate in data review as specified in the Data Review Plan.

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.

Background:

• Advanced degree or equivalent education/degree in life science/healthcare recommended.
• Fluent English (oral and written).
• Good communication, organization and tracking skills.
• Basic knowledge of Good Clinical Practice; basic knowledge of clinical trial design; basic knowledge of scientific principles.

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