Junior Clinical Development- Temporary
il y a 20 jours
Toledo
In short Position: Junior Clinical Development Location: Azuqueca de Henares. Experience: 3 to 5 years in similar roles. Want to know more? NSUD 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. INSUD 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 R&D 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. What are we looking for? Planning, 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. The challenge! Support 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). Prepare 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. Participate 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). Support 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. Coordinate 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. Support interactions with Health Authorities, including Scientific Advice procedures, Deficiency Letters, and other regulatory communications. Collaborate with cross-functional departments and experts (e.g. Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management, Legal) to support project strategies and execution plans. Contribute to the maintenance of the GCP system through the preparation, review, and update of SOPs and related quality documentation. Support pipeline evaluation and due diligence activities (clinical strategy, timelines, and cost of new clinical programs), if required by the pipeline committee group. Review, 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. Support study budget planning and follow-up for assigned studies. Collaborate with Trainees, Clinical Trials Assistants or Clinical Research Associates when applicable. Specific Knowledge: Previous experience in Clinical Research, Clinical Operations, Clinical Development, or a related area is desirable. Basic to good understanding of global Clinical Development processes, preferably with exposure to PK and BE studies. Basic knowledge of applicable clinical trial regulations and guidelines, including ICH, EMA, FDA, and GCP. Understanding of study documentation and clinical trial processes across study start-up, conduct, and close-out. Exposure to study design, vendor coordination, site-related activities, and operational support in a clinical development environment. Desirable knowledge of generic drug development and related methodologies, including PK/BE studies, dissolution data, bioanalytical aspects, and in vitro/in vivo considerations. Willingness to travel occasionally, if required, for business needs (less than 5% of the time). Experience (years/area): Mandatory: University Degree in Medicine, Pharmacy or Life Science. Desired: Master's degree in clinical trials monitoring, Clinical trials project management, Pharmaceutical Industry or related field. Fluent in English required, communicative level in Spanish preferred, knowledge of other languages will be an asset. Ability to work effectively in cross-functional teams in an international environment. Proactive problem-solving and analytical thinking skills. Effective interpersonal and communication skills. Strong organizational skills, attention to detail, a
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