Regulatory & Start-Up Manager, IQVIA MedTech, Portugal & Spain
Job Title: Regulatory & Start-Up Manager, IQVIA MedTech, Portugal & Spain
Job Location: Oeiras, Portugal
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
Regulatory & Start Up Manager
Portugal/Spain
IQVIA Medtech
Homebased
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
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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.
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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.
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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.
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Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
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Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
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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.
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Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
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Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
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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.
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Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
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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.
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Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
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May take a lead role in developing long standing relationships with preferred IQVIA customers.
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Deliver presentations/training to clients, colleagues and professional bodies, as required.
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May be involved in activities related to monthly study budget planning and reviews.
Qualifications and Skills
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Bachelor's Degree Life sciences or related field
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5 - 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in a global role
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Spanish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees
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Proven experience in Regulatory Submissions for Medical Devices
- EU CTR experience essential
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Strong negotiation and communication skills with ability to challenge
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Excellent interpersonal skills and strong team player
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Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
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Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
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Demonstrated proficiency in using systems and technology to achieve work objectives