Direct and manage the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, scope of work oversight, budget, and resources.
Home-based role requiring experience with medical devices submissions (MD / IVD), site activation oversight, and Spanish language fluency.
Essential Functions
Oversee the execution of site activation (including pre-award / bid defense activities) and / or maintenance for assigned projects, ensuring adherence to project timelines and RSU site activation strategy.
Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, resolving project-related issues as needed.
Ensure collaboration across Regulatory & Site Activation teams, including communication with regions and countries, to successfully deliver project scope in compliance with the RSU Management Plan.
Create and review technical and administrative documentation to support business development and enable study initiation and maintenance.
Provide regulatory and technical scientific support to facilitate clinical trial processes, ensuring compliance with regulatory requirements.
Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance phases as part of the study management team.
Determine regulatory strategies and expectations for submissions and authorizations, identify regulatory challenges, and propose solutions to support site activation plans.
Assess the regulatory landscape and contribute to the collection and analysis of regulatory intelligence to support studies and the company.
Execute operational strategies for maintaining study approvals and authorizations, including contract and document negotiations.
Collaborate with Quality Management to uphold quality standards during site activation and maintenance. Mentor colleagues and ensure accurate documentation and system updates.
Develop relationships with key clients, deliver presentations and training, and participate in budget planning and reviews as needed.
Qualifications
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J-18808-Ljbffr
J-18808-Ljbffr
Regulatory And Start • Madrid, Comunidad de Madrid, España