Regulatory And Start Up Specialist

hace 3 semanas

Madrid, España Precision Medicine Group A tiempo completo

Regulatory and Start Up Specialist - Clinical Trial ServicesLocation: Madrid, SpainJob Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision for Medicine is not your typical CRO.
We have brought together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients.
What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.As our organization continues to grow, we are hiring aRegulatory and Start Up Specialist/Senior Regulatory and Start Up Specialistto join our team inSpain.
This position can be offered fully home-based.Essential functions of the job include but are not limited to:Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.Preparation of Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines.Interaction with CA/EC for study purposes and handling responses to the CA/EC.Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.Maintenance of project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities.Preparation/Support the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.Customize country/site specific Patient Information Sheet and Informed Consent Form.Responsible for/facilitates the translation and coordination of translations for documents.Maintain communication with other key functions participating in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group.Act as SME for collection and maintenance of site-level critical path to Site Activation data points.When required, participate/support the negotiation of study budgets and the execution of investigator contracts.May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.Keep an updated knowledge of the local clinical trial laws and regulations.Maintain audit/inspection readiness at all times and file documents as per TMF plan.May support the clinical team performing Pre-Study Site Visits.Experience / QualificationsBachelor's degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry.Regulatory/ SU experience for covering Belgium and the Netherlands.Other Required:Strong communication and organizational skills.Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.Fluency in English.Preferred:Relevant regulatory and site start-up experience.Experience using milestone tracking tools/systems.Ability to prioritize workload to meet deadlines.Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.We invite you to learn more about our growing organization serving our clients researching groundbreaking cancer therapies.
We strive to ensure employees feel appreciated for their contributions.
You will provide input and have your ideas valued, impacting positive change for the company.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in your ability to access or use this online application process, you may contact Precision Medicine Group at ******.#J-18808-Ljbffr

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job Title: Regulatory and Start-Up SpecialistPrecision Medicine Group is a leading provider of clinical trial services, and we are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain. This is a unique opportunity to work with a dynamic organization that is pushing the boundaries of medical research.Key...

  • Regulatory And Start Up Specialist

    hace 3 semanas

    Madrid, España Precision Medicine Group, Llc. A tiempo completo

    .Regulatory and Start Up Specialist - Clinical Trial Services Location: Madrid, Spain Job Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision for Medicine is not your typical CRO. We have brought together new technologies, expertise, and operational scale to help the life sciences improve...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job Title: Regulatory and Start-Up SpecialistLocation: Madrid, SpainJob Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision Medicine Group is a leading provider of clinical trial services. We are seeking a Regulatory and Start-Up Specialist to join our team in Spain. This position can be...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job Title: Regulatory and Start-Up SpecialistAt Precision Medicine Group, we are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain. This role will be responsible for ensuring the timely and quality delivery of site activation readiness within assigned countries/sites, as well as foreseeing and mitigating any risks.Key...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory and Start-Up SpecialistPrecision for Medicine is a pioneering CRO that combines cutting-edge technologies, expertise, and operational scale to accelerate the development of life-changing therapies. We're seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain, with the option to work fully remotely.Key...

  • Regulatory And Start Up Specialist

    hace 3 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Regulatory and Start Up Specialist - Clinical Trial Services Location: Madrid, Spain Job Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision for Medicine is not your typical CRO. We have brought together new technologies, expertise, and operational scale to help the life sciences improve...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group, Llc. A tiempo completo

    Regulatory and Start-Up SpecialistAt Precision Medicine Group, LLC., we are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain. This role can be offered fully home-based.Key Responsibilities:Deliver site activation readiness within assigned countries/sites, ensuring timeliness and quality.Prepare and submit Clinical Trial...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job SummaryPrecision for Medicine is a unique Contract Research Organization (CRO) that combines cutting-edge technologies, expertise, and operational scale to accelerate the development of life-changing therapies. We are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain, working fully remotely.Key ResponsibilitiesEnsure...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Precision Medicine Group, Llc. A tiempo completo

    Job Title: Regulatory and Start-Up SpecialistLocation: Madrid, SpainJob Type: Regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4749Precision for Medicine is a leading CRO that combines new technologies, expertise, and operational scale to improve the speed, cost, and success rate of bringing life-changing...

  • Regulatory and Start-Up Specialist

    hace 3 semanas

    Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory and Start-Up SpecialistPrecision for Medicine is a leading Contract Research Organization (CRO) that combines innovative technologies, expertise, and operational scale to accelerate the development of life-changing therapies. We are seeking a highly skilled Regulatory and Start-Up Specialist to join our team in Spain. This role can be offered...

  • Regulatory And Start Up Specialist

    hace 3 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory And Start Up Specialist

    hace 3 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory and Start Up Specialist

    hace 3 días

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory And Start Up Specialist

    hace 3 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory and Start Up Specialist 2

    hace 3 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    Job OverviewAs a Regulatory and Start Up Specialist 2 at IQVIA, you will play a critical role in ensuring the successful activation of clinical trial sites worldwide. Your expertise in regulatory compliance and start up processes will be instrumental in ensuring that all sites are properly set up and ready for trial initiation.Key ResponsibilitiesServe as...

  • Regulatory And Start Up Specialistnew

    hace 4 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory and Start Up Specialist 2

    hace 3 semanas

    Madrid, Madrid, España IQVIA A tiempo completo

    Job OverviewAs a Regulatory and Start Up Specialist 2 at IQVIA, you will be responsible for performing 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.Key...

  • Regulatory And Start Up Specialistnew

    hace 3 semanas

    Madrid, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory And Start Up Specialist New Madrid, Madrid, Spain

    hace 3 semanas

    Madrid, España Tbwa ChiatDay Inc A tiempo completo

    .Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory And Start Up Specialist New Madrid, Madrid, Spain

    hace 3 semanas

    Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...