Regulatory and Start Up Manager

hace 2 semanas

Madrid, España IQVIA A tiempo completo

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. Fluent in Spanish and English.

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
Bachelor's Degree Life sciences or related field Req
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.

Strong negotiation and communication skills with ability to challenge. 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 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. 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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

  • Regulatory and Start Up Manager

    hace 2 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    Job OverviewDirect 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. Fluent in Spanish and English.Essential Functions Oversee the execution of Site Activation (including...

  • Regulatory and Start Up Manager

    hace 1 mes

    Madrid, España Novasyte A tiempo completo

    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. #LI-Remote Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense...

  • Senior Regulatory

    hace 1 mes

    Madrid, España Novasyte A tiempo completo

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...

  • Regulatory and Start Up Specialist 1

    hace 3 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    ob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 1 years' experience with submissions and CTIS...

  • Clinical Operation Manager Regulatory and Start Up

    hace 1 mes

    Madrid, España Novasyte A tiempo completo

    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)...

  • Assoc Project Manager, Start-up

    hace 1 mes

    Madrid, España Labcorp A tiempo completo

    **Labcorp Drug Development** As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services...

  • Associate Project Manager Start Up

    hace 1 semana

    Madrid, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Global Regulatory Manager

    hace 1 día

    Madrid, España Allucent A tiempo completo

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). The Global Regulatory Manager is responsible for managing...

  • Associate Project Manager Start Up

    hace 1 semana

    Madrid, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Local Start-Up Specialist I/II

    hace 4 días

    Madrid, España Allucent A tiempo completo

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and...

  • Local Start-Up Specialist I/II

    hace 4 días

    Madrid, España Allucent A tiempo completo

    At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates...

  • Cta Start Up

    hace 1 mes

    Madrid, España ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: - Transversal collaboration with each of the teams’ members within...

  • Preclinical And Regulatory Project Manager

    hace 4 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project Manager We are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Preclinical And Regulatory Project Manager

    hace 4 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project Manager We are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Associate Project Manager Start Up

    hace 4 semanas

    Madrid, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Regulatory Manager

    hace 4 semanas

    Madrid, España Precision For Medicine A tiempo completo

    Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. Position Summary: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings,...

  • Study Start Up Associate I

    hace 2 días

    Madrid, España ICON plc A tiempo completo

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate II

    hace 4 días

    Madrid, Madrid, España ICON Clinical Research A tiempo completo

    Study Start Up Associate IIAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &...

  • Preclinical And Regulatory Project Manager

    hace 4 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project ManagerWe are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Regulatory Compliance Project Manager

    hace 4 semanas

    Madrid, España SGS A tiempo completo

    Company Description We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. **Job Description**: We...