Buscar empleo: 68 ofertas de trabajo de director en Alovera (julio 2026)

Junior Clinical Development- Temporary

hace 1 día

Azuqueca de Henares

ppExperience: 3 to 5 years in similar roles. /p pNSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal health. /p pINSUD PHARMA’s activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 10,000 professionals in over 50 countries, 20 state‑of‑the‑art facilities, 15 specialized RD centers, 12 commercial offices, and more than 35 pharmaceutical affiliates, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. /p h3What are we looking for? /h3 pPlanning, designing, organization, supervision of conduct and reporting of clinical trial contracted to Clinical Research Organizations (CRO) to enable studies execution within the planned timelines and in compliance with current GCP and other applicable requirements. The main focus is on pharmacokinetic (PK) and bioequivalence (BE) trials. Multicenter clinical trials and phase II and III trials may also be required with the necessary support. /p h3Responsibilities /h3 ul liSupport the design and day‑to‑day management of clinical/preclinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others). /li liPrepare and maintain the appropriate documents to support clinical strategy, study rationale, and justifications, and communicate effectively with the rest of the team involved (CRA/CTA) as well as with the reporting line Team Leader/Manager. /li liParticipate in the selection and coordination of CROs and other external vendors, and support follow‑up of contracted activities to help ensure that activities are conducted in accordance with agreed requirements (cost, quality, and time). /li liSupport the review of the necessary documentation before (e.g. Protocol, ICF, etc.), during (e.g. Monitoring, etc.), and at the end (e.g. Study Report, etc.) of clinical trials. /li liCoordinate and follow up internal activities and procedures related to study conduct and operational execution of clinical trials (e.g. investigational medication shipment, etc.), ensuring alignment with internal processes. /li liSupport interactions with Health Authorities, including Scientific Advice procedures, Deficiency Letters, and other regulatory communications. /li liCollaborate with cross‑functional departments and experts (e.g. Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management, Legal) to support project strategies and execution plans. /li liContribute to the maintenance of the GCP system through the preparation, review, and update of SOPs and related quality documentation. /li liSupport pipeline evaluation and due diligence activities (clinical strategy, timelines, and cost of new clinical programs), if required by the pipeline committee group. /li liReview, summarize, and communicate clinical study results accurately and effectively to the reporting line and relevant stakeholders (Team Leader/Manager/Director, etc.), escalating issues as appropriate. /li liSupport study budget planning and follow‑up for assigned studies. /li liCollaborate with Trainees, Clinical Trials Assistants or Clinical Research Associates when applicable. /li liPrevious experience in Clinical Research, Clinical Operations, Clinical Development, or a related area is desirable. /li liBasic to good understanding of global Clinical Development processes, preferably with exposure to PK and BE studies. /li liBasic knowledge of applicable clinical trial regulations and guidelines, including ICH, EMA, FDA, and GCP. /li liUnderstanding of study documentation and clinical trial processes across study start‑up, conduct, and close‑out. /li liExposure to study design, vendor coordination, site‑related activities, and operational support in a clinical development environment. /li liDesirable knowledge of generic drug development and related methodologies, including PK/BE studies, dissolution data, bioanalytical aspects, and in vitro/in vivo considerations. /li liWillingness to travel occasionally, if required, for business needs (less than 5% of the time). /li /ul h3Qualifications /h3 ul liMandatory: University Degree in Medicine, Pharmacy or Life Science. /li liDesired: Master’s degree in clinical trials monitoring, Clinical trials project management, Pharmaceutical Industry or related field. /li liFluent in English required, communicative level in Spanish preferred, knowledge of other languages will be an asset. /li liAbility to work effectively in cross‑functional teams in an international environment. /li liProactive problem‑solving and analytical thinking skills. /li liEffective interpersonal and communication skills. /li liStrong organizational skills, attention to detail, and ability to manage priorities and timelines. /li liReliable and accountable approach to assigned responsibilities. /li liCuriosity, willingness to learn, and openness to feedback. /li liStrong commitment to quality, compliance, data integrity, and ethical standards. /li /ul h3Benefits /h3 ul liFlexible start hours from Monday to Friday (full 40‑hour workweek). /li liAttractive salary package. /li liCompany cafeteria (free of charge). /li liBenefits and Savings Club. /li liDevelopment plans, internal mobility policy. /li /ul h3Commitment to Equal Opportunities /h3 pThe InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as established 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. /p /p #J-18808-Ljbffr

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