Associate Maintenance Lead, Clinical Research

hace 4 días

Buenos Aires, Argentina IQVIA A tiempo completo

**Assoc. Maintenance Lead - Homebased.**
- _Please submit your CV in English* _

Job Overview

As **Assoc.**Maintenance Lead**you will be responsible of d irect 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.

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