Clinical Research Associate - Chemo
il y a 11 jours
Azuqueca de Henares
Position: Clinical Research Associate Location: Azuqueca de Henares. Experience: 2 to 4 years in similar roles. Do you want to know more?👇 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. 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 R&D 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. Are you ready to be a #Challenger? The challenge! • Collaborate with Clinical Development Leaders to execute assigned trials aligned with the product development plan., • Take ownership of trial execution, reporting, and evaluation, ensuring compliance with GCP and applicable regulations., • Support clinical trial activities according to ICH/EMA/FDA and other relevant guidelines., • Participate in the selection of CROs and external vendors; oversee contracted activities (cost, quality, timelines)., • Review key trial documentation (e.g., Protocol, ICF, monitoring oversight, study report)., • Work closely with sponsor teams, CROs, and site staff in multidisciplinary environments., • Oversee monitoring documentation (e.g., MVRs), SDV quality, and site readiness/compliance., • Oversee training of site staff on protocols, safety reporting, and GCP., • Oversee IP handling, storage, and accountability at sites., • Proactively identify risks and drive corrective and preventive actions (CAPA)., • Coordinate internal CHEMO activities linked to trial conduct (e.g., investigational product shipments)., • Partner with cross-functional teams (Pharm Dev, Regulatory, PV, Project Management) to support execution., • Contribute to GCP system maintenance through SOP development/review. What do you need? • University degree in a Life Sciences discipline (mandatory), • 2+ years in a similar CRA/clinical trial oversight role, • Experience in global clinical development and trial implementation (site selection/management, monitoring activities), • Remote and on-site monitoring exposure, including risk-based monitoring (RBM), • Strong understanding of ICH-GCP, FDA, EMA, and local regulatory requirements, • Skilled in identifying/documenting/escalating AEs/SAEs, • Experience preparing and reviewing study documentation, • Fluent English required, • Strong cross-functional collaboration in international settings, • Proactive, hands-on, “can-do” mindset with strong ownership, • Excellent organization, attention to detail, communication, and time management, • Comfortable with Microsoft Office for reporting/documentation, • Sound judgment, curiosity, and willingness to learn Our benefits! ⏰Flexible entry schedule from Monday to Friday (full-time, 40 hours). 📜Permanent contract 💸Attractive salary package. 🥼 Life and accident insurance. 🍽️ Company cafeteria (free). 🥼 Co-payment on voluntary health insurance. 💸Benefits & Savings Club. 📈Development plans, internal mobility policy. ⭐And many more! How will the selection process be? 🕵️ ➡️Stay alert to your phone and email! Most likely, the first thing we will do is contact you through one of these channels. ➡️Get ready! We will continue with an in-person/virtual interview depending on availability and as we agree; the process may include one or two interviews, and depending on the type of process, there may also be some sort of test. ➡️Wait for the result! We care that in each selection process you feel guided and know what to expect from us, so we will try to inform you about the status of the process at all times. 🔷Do you think this offer is not for you?🔷 Follow us on social media like LinkedIn/Instagram and stay tuned for any openings we post: the opportunity to become a new Insuder is waiting! #InsudPharma #Challenger #Insuder #InsudTalent COMMITMENT TO EQUAL OPPORTUNITIES The InsudPharma group is aware that business management must be in harmony with the needs and demands of society, and therefore undertakes a commitment to equal opportunity and treatment between men and women, as set out in current regulations—Organic Law 3/2007—and we do not discriminate against anyone based on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
