Empleos actuales relacionados con Regulatory and Start Up Specialist - Madrid - Precision Medicine Group
-
Regulatory Affairs Study Start Up Specialist II
hace 2 semanas
Madrid, España CTI Clinical Trial and Consulting Services A tiempo completoRegulatory Affairs Study Start Up Specialist II (RASSU)Dé el siguiente paso en su carrera profesional ahora: desplácese hacia abajo para leer la descripción completa del puesto y envíe su solicitud.Join to apply for theRegulatory Affairs Study Start Up Specialist II (RASSU)role atCTI Clinical Trial and Consulting ServicesWhat You’ll DoPrepare, review,...
-
Regulatory Affairs Study Start Up Specialist II
hace 6 días
Madrid, España CTI Clinical Trial and Consulting Services A tiempo completoRegulatory Affairs Study Start Up Specialist II (RASSU) Join to apply for the Regulatory Affairs Study Start Up Specialist II (RASSU) role at CTI Clinical Trial and Consulting Services What You’ll Do Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. Handle regulatory submissions for medical devices, GMOs,...
-
Clinical Trials Start-Up Lead
hace 6 días
Madrid, España ICON A tiempo completoA leading healthcare intelligence organization in Madrid is seeking a Site and Study Start Up Specialist to lead the initiation of clinical trials and ensure compliance with regulations. The ideal candidate will have a Bachelor's degree in life sciences and at least 2 years of experience in clinical research or regulatory affairs. Excellent organizational...
-
Clinical Trials Start-Up Lead
hace 5 días
Madrid, España ICON A tiempo completoA leading healthcare intelligence organization in Madrid is seeking a Site and Study Start Up Specialist to lead the initiation of clinical trials and ensure compliance with regulations. The ideal candidate will have a Bachelor's degree in life sciences and at least 2 years of experience in clinical research or regulatory affairs. Excellent organizational...
-
Clinical Trials Start-Up Lead
hace 3 días
Madrid, España ICON A tiempo completoA leading healthcare intelligence organization in Madrid is seeking a Site and Study Start Up Specialist to lead the initiation of clinical trials and ensure compliance with regulations. The ideal candidate will have a Bachelor's degree in life sciences and at least 2 years of experience in clinical research or regulatory affairs. Excellent organizational...
-
Clinical Trials Start-Up Lead
hace 1 semana
Madrid, España ICON A tiempo completoA leading healthcare intelligence organization in Madrid is seeking a Site and Study Start Up Specialist to lead the initiation of clinical trials. The role involves preparing regulatory submissions and coordinating with stakeholders for approvals. The ideal candidate will have a Bachelor's degree in life sciences, at least 2 years of experience in clinical...
-
Clinical Trials Start-Up Lead
hace 3 días
Madrid, España ICON A tiempo completoA leading healthcare intelligence organization in Madrid is seeking a Site and Study Start Up Specialist to lead the initiation of clinical trials. The role involves preparing regulatory submissions and coordinating with stakeholders for approvals. The ideal candidate will have a Bachelor's degree in life sciences, at least 2 years of experience in clinical...
-
Regulatory Affairs Study Start Up Specialist II
hace 2 semanas
Madrid, España Consulting, Inc. A tiempo completoRegulatory Affairs Study Start Up Specialist II (RASSU)Todos los candidatos deben asegurarse de leer atentamente la siguiente descripción del puesto y la información antes de enviar su solicitud.Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS.Handle regulatory submissions for medical devices, GMOs, and...
-
Regulatory and Start Up Manager, IQVIA MedTech, Spain
hace 2 semanas
Madrid, España IQVIA LLC A tiempo completoRegulatory and Start Up Manager, IQVIA MedTech, Spain page is loaded## Regulatory and Start Up Manager, IQVIA MedTech, Spainlocations:Asegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.Madrid, Spaintime type:Full timeposted on:Posted Todayjob requisition...
-
Regulatory & Start-Up Lead, MedTech (Spain)
hace 1 semana
madrid, España IQVIA LLC A tiempo completoA leading life sciences company is seeking a Regulatory and Start Up Manager in Madrid to oversee site activation and regulatory activities for selected studies. The role requires a Bachelor's Degree in Life Sciences, 7 years of experience in a scientific environment, and proficiency in Spanish. Candidates should possess strong negotiation skills, a thorough...
Regulatory and Start Up Specialist
hace 3 semanas
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry‑leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.Essential functions of the job include but are not limited toResponsible 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 the submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH‑GCP.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 and to keep Regulatory Leadership informed.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 (Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management group) on project specific status and deliverables.Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.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, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF.May support the clinical team performing Pre‑Study Site Visits.Minimum RequiredBachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.A qualification in Pharmacy / work experience as a Pharmacist would be highly beneficial.1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.Other RequiredStrong communication and organizational skills.Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.Fluency in English.PreferredRelevant regulatory and site start‑up (feasibility, contract negotiations, CA/EC/IRB submissions) 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, or Masters in Regulatory Science.We invite you to learn more about our growing organization serving our clients that are researching ground‑breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.#J-18808-Ljbffr
