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Clinical research associate

Azuqueca de Henares
Chemo
Publicada el Publicado hace 5 hr horas
Descripción

P Position: Clinical Research Associate /pp Location: Azuqueca de Henares. /pp Experience: 2 to 4 years in similar roles. /p pb Do you want to know more? /b /p p INSUD PHARMA operates throughout the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to both human and animal health. /pp INSUD PHARMA’s activity is structured into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized RD centers, 12 commercial offices, and over 35 pharmaceutical subsidiaries, serving 1,150 clients in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. /pp Are you ready to be a #Challenger? /p pb The challenge! /b /p ulli Collaborate with Clinical Development Leaders to execute assigned trials aligned with the product development plan. /lili Take ownership of trial execution, reporting, and evaluation, ensuring compliance with GCP and applicable regulations. /lili Support clinical trial activities according to ICH/EMA/FDA and other relevant guidelines. /lili Participate in the selection of CROs and external vendors; oversee contracted activities (cost, quality, timelines). /lili Review key trial documentation (e.g., Protocol, ICF, monitoring oversight, study report). /lili Work closely with sponsor teams, CROs, and site staff in multidisciplinary environments. /lili Oversee monitoring documentation (e.g., MVRs), SDV quality, and site readiness/compliance. /lili Oversee training of site staff on protocols, safety reporting, and GCP. /lili Oversee IP handling, storage, and accountability at sites. /lili Proactively identify risks and drive corrective and preventive actions (CAPA). /lili Coordinate internal CHEMO activities linked to trial conduct (e.g., investigational product shipments). /lili Partner with cross-functional teams (Pharm Dev, Regulatory, PV, Project Management) to support execution. /lili Contribute to GCP system maintenance through SOP development/review. /li /ul pb What do you need? /b /p ulli University degree in a b Life Sciences /b discipline (mandatory) /lilib2+ years /b in a similar CRA/clinical trial oversight role /lili Experience in b global clinical development /b and trial implementation (site selection/management, monitoring activities) /lili Remote and on-site monitoring exposure, including b risk-based monitoring (RBM) /b /lili Strong understanding of b ICH-GCP /b, b FDA /b, b EMA /b, and local regulatory requirements /lili Skilled in identifying/documenting/escalating b AEs/SAEs /b /lili Experience preparing and reviewing study documentation /lili Willingness to travel b~10% /b /li /ulpb Languages /b /pullib Fluent English /b required /lilib Spanish /b (communicative level) is a plus; other languages are an asset /li /ulpb Skills /b /pulli Strong cross-functional collaboration in international settings /lili Proactive, hands-on, “can-do” mindset with strong ownership /lili Excellent organization, attention to detail, communication, and time management /lili Comfortable with Microsoft Office for reporting/documentation /lili Sound judgment, curiosity, and willingness to learn /li /ul pb Our benefits! /b /p p⏰Flexible entry schedule from Monday to Friday (full-time, 40 hours). /pp Permanent contract /pp Attractive salary package. /p

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