Regulatory and Start Up Manager

hace 2 semanas


En remoto, 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
- 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.



  • En remoto, 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...


  • En remoto, 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. **Essential Functions** - Oversee the execution of Site Activation (including pre-award/bid defense...


  • En remoto, España IQVIA A tiempo completo

    **Associate Study Start-Up Manager** **IQVIA Biotech** 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...

  • Global Regulatory Manager

    hace 3 semanas


    En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...


  • En remoto, España VRS Regulatory A tiempo completo

    We are looking for an experienced regulatory ecotoxicologist to work as a technical specialist in a multi-disciplinary registrations team. The role will involve acting as the department ecotox expert, you will mentor more junior ecotoxicologists and provide expert advice and guidance to external stakeholders. The role will involve supporting large...

  • Director, Start-up

    hace 3 semanas


    En remoto, España Innovaderm Research A tiempo completo

    The Director, Start-Up is responsible for providing leadership and oversight to site contracting, and site activation teams, ensuring alignment with study and site activation timelines. The Director, Start-Up will provide leadership to functional leads of Site Selection and Site Contracting. The Director, Start Up has line management responsibility for...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You'll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you'll help make a positive difference in patients'...


  • En remoto, España Luka Global Group A tiempo completo

    **Job Information**: Industry - Digital Health Remote Job This is a remote position. A Quality and Regulatory Affairs Manager is sought to join an expanding Digital Health Start-Up. If you are passionate about world-class MedTech products, solving real-world problems and making a difference in patients’ lives this could be the role for you! The role...


  • En remoto, España IQVIA A tiempo completo

    You will 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. The role may also include maintenance activities. This is not a line management position but requires...


  • En remoto, España Innovaderm Research A tiempo completo

    The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...


  • En remoto, España Luka Global Group A tiempo completo

    Job Information:Industry Medical DevicesRemote JobThis is a remote position._ To be eligible you must have commercial experience in Orthopaedic Medical Devices_As the CEO/Co-Founder of this early stage venture you will drive the project to hit milestones with a strategic exit in mind. The role is a remote position preferably within either the US or...


  • En remoto, España EWOR GmbH A tiempo completo

    We at EWOR started in 2017 with the idea to create a system that allows people to build companies next to universities and their jobs. Since then, we've helped people raise million-dollar rounds after our programs and have seen our students build businesses such as Patchwork Hub, Flike App, NUWE, Tanso, and many more. Participate in a 10-month fully...


  • En remoto, España Luka Global Group A tiempo completo

    **Job Information**: Industry - Biotechnology Remote Job This is a remote position. Our client is a biotech start-up founded in 2021 by a prestigious European biotech research institute and their venture partners. Currently, in stealth mode, they are developing innovative therapies for treating neurodegenerative and neurological disorders focusing on...


  • En remoto, España Pfizer A tiempo completo

    The Study Operations Manager II is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager II...

  • Senior Project Manager

    hace 3 semanas


    En remoto, España ICON A tiempo completo

    As a Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations...


  • En remoto, España Illumina A tiempo completo

    What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases...


  • En remoto, España Revolut A tiempo completo

    About Revolut People deserve more from their money. More visibility, more control, more freedom. And since 2015, Revolut has been on a mission to deliver just that. With an arsenal of awesome products that span spending, saving, travel, transfers, investing, exchanging and more, our super app has helped 25+ million customers get more from their money. And...


  • En remoto, España Blu Selection A tiempo completo

    Our client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions.TasksYour Responsibilities and Impact as Regulatory Affairs Manager will be:Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and practices...


  • En remoto, España Blu Selection A tiempo completo

    Our client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions. Tasks Your Responsibilities and Impact as Regulatory Affairs Manager will be: - Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and...


  • En remoto, España EWOR GmbH A tiempo completo

    At EWOR, we offer a 10-month, fully-sponsored Fellowship programme designed to assist entrepreneurial individuals in launching their own venture. The programme provides a master's degree like education in entrepreneurship, an introduction to successful entrepreneurs and unicorn founders, and assistance in securing funding from prominent investors....