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Regulatory and Start-Up Manager
hace 2 meses
Job Summary
Iqvia Llc is seeking a highly skilled Regulatory and Start-Up Manager to join our team. As a key member of our organization, you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs.
Key Responsibilities
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project-related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations, and review/negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
- Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project-specific information.
- May take a lead role in developing long-standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues, and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.
