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Assoc. Maintenance Lead - Homebased.

*Please submit your CV in English*

Job Overview

As Assoc. Maintenance Lead you will be responsible of direct and manage the delivery of all required maintenance and regulatory activities for selected global studies or multi-protocol programs.

The Role

• Provides strategic planning and project oversight accelerating implementation of revised clinical study documents through best in class project management to ensure fast implementation.

• Support and/or participate in pre-award/bid defense activities, for transitioned studies from other CROs/Pharma.

• Oversee the execution of Lifecycle Maintenance for assigned projects in accordance with the agreed strategy, adhering to agreed project timelines and in compliance with regulatory requirements.

• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.

• Collaborate with key stakeholders both internal and external, through effective communication and resolution management, to successfully deliver the agreed project scope.

• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.

Requirements

• Bachelor's degree in life sciences or related field.

• 3 years of Clinical Research experience, including 1 year experience in a leadership capacity.

• Advanced English level.

• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.

• Strong negotiation and communication skills.

• Effective organizational, leadership and interpersonal skills.

• Effective presentation skills.

• Ability to work independently and to effectively prioritize tasks.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com