Job Overview
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, oversight of the scope of work, budget and resources.
Essential Functions
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 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).
Qualifications
- Equivalent combination of education, training and experience.
- Full knowledge of drug development process
- Full knowledge of applicable regulatory requirements, SOPs, and company's Corporate Standards
- Strong knowledge of budget management and resourcing
- Considerable working knowledge of medical terminology
- Strong knowledge of Microsoft Office and e-mail applications
- Effective communication, organizational, interpersonal, and leadership skills
- Strong negotiation skills
- Ability to independently coordinate and manage new processes
- Ability to work well within a matrix team environment
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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