Start Up Specialist
hace 2 semanas
Start Up Specialist / Site Readiness and Reg Specialist II - FSPx Team - SpainFortrea, Madrid, Community of Madrid, SpainJoin Our Team and Drive Clinical Research SuccessAt Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start‑Up Specialist, you will play a pivotal role in coordinating site start‑up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life‑changing treatments to patients faster.In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsors to advance the development of innovative, life‑changing medications.Key ResponsibilitiesServe as the primary contact for investigative sites during start‑up and maintenance activities.Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.Prepare and submit regulatory documents, including country‑specific application forms and informed consent forms.Track submission timelines and proactively address potential delays.Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.Ensure all documentation is audit‑ready and systems are consistently updated.Assist in the negotiation of site contracts and budgets, if applicable.Provide mentorship and training to new hires and less‑experienced colleagues.Required QualificationsUniversity/College degree (life sciences preferred) or certification in a related allied health profession.Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start‑up processes.Ability to review and adapt patient informed consent forms to meet local and protocol‑specific requirements.Experience interacting with regulatory authorities and site start‑up teams.Excellent organizational, problem‑solving, and communication skills.Proficiency in Microsoft Office and document management systems.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.What We OfferCompetitive salary and performance‑based incentives.Flexible work arrangements (remote/hybrid options).Professional growth opportunities in a collaborative and innovative environment.The opportunity to work on cutting‑edge clinical research projects.Learn more about our EEO & Accommodations request here.#J-18808-Ljbffr
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Start Up Specialist
hace 5 días
Madrid, Madrid, España Fortrea A tiempo completoJoin Our Team and Drive Clinical Research SuccessAt Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will...
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QA & RA Specialist, IVD Start-up — Barcelona
hace 3 días
madrid, España Barrington James A tiempo completoAn innovative IVD start-up in Madrid is looking for a Junior QA / RA Specialist to establish their Quality & Regulatory function. The role involves supporting ISO 13485 compliance, preparing regulatory submissions, and engaging with Notified Bodies. Ideal candidates should have 3-5 years of experience in QA / RA, knowledge of EU IVDR and ISO 13485, and...
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Regulatory and Start Up Specialist
hace 3 días
Madrid, España IQVIA LLC A tiempo completoRegulatory and Start Up Specialist page is loaded## Regulatory and Start Up Specialistlocations: Madrid, Spain: Barcelona, Spaintime type: Full timeposted on: Posted Todayjob requisition id: R **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations,...
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Senior Oncology Study Start-Up Specialist
hace 1 día
madrid, España Kapadi A tiempo completoA clinical research organization is seeking a Clinical Research Associate III in Madrid to handle study start-up and maintenance for oncology trials. The role involves managing site activities, maintaining compliance with regulations, and coordinating with project teams. Candidates should have a Bachelor's Degree in a relevant field, with over 5 years of...
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Start-Up, Project Manager
hace 2 semanas
Madrid, Madrid, España Indero (formerly Innovaderm) A tiempo completoThe Start-Up Manager is responsible for overseeing and managing the successful and timely activation of clinical trial sites across multiple countries. This role leads all start-up activities, ensures regulatory compliance, and collaborates with cross-functional teams to meet study timelines and client expectations. The ideal candidate will bring strategic...
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Senior Manager, Study Start Up
hace 6 días
Madrid, España ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Global Start Up Assistant
hace 2 semanas
Madrid, España Allucent A tiempo completoAt 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 Start-Up Assistant to join our A-team! The Global Start-up Assistant (GSUA) provides administrative support to all...
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Study Start Up Manager
hace 6 días
Madrid, España Ergomed A tiempo completoCompany Description Ergomed is a rapidly growing global clinical research company. We perform clinical trials for rare and complex diseases. Ergomed Plc is a public company on the London stock exchange. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent...
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Study Start Up Lead
hace 3 días
Madrid, España Roche A tiempo completoThe Position At Roche / Genentech Pharma Product Development Global Clinical Operations (PDG) we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. As a key member of our Country Study Start‑Up team you will drive and facilitate...
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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,...