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
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.
Qualifications and Skills
Bachelor's Degree Life sciences or related field
5 - 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in a global role
Spanish language proficiency is essential for direct communication with the Competent Authority and Ethics Committees
Proven experience in Regulatory Submissions for Medical Devices
EU CTR experience essential
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and/or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
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