CLINICAL DEVELOPMENT LEADER JUNIOR

About us:Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).We are looking for a Junior Clinical Development for our plant, Liconsa (Madrid) or our offices in Barcelona.Overview:Contribute in the 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.Responsabilities:Support the Clinical Development Leader in the overall responsibility for the plan, design, execution, reporting and evaluation of results of clinical trials as well as assure conduct of the trials in compliance with applicable requirements including but not limited to GCP. Specific responsibilities include:Participate in the design and manage of the clinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others).Participate in the selection of CROs and other external vendors and control the execution of all contracted activities and ensure that the activities are conducted in accordance with the requirements (cost, quality, and time).Participate in the review 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.Participate in the coordination of internal Chemo activities and procedures related with the conduct of the clinical trials (e.g. investigational medication shipment, etc.).Collaborate in the interaction with Health Authorities: Scientific Advices and Deficiency Letters.Collaborate with other departments and experts (e.g. in Pharmaceutical Development, Regulatory, Pharmacovigilance, Project Management) to define strategies and plans for projects execution and execute clinical activities according to agreed plans.Participate on the maintenance of GCP system through elaboration and/or review of SOPs, etcQualifications:Education:Mandatory: Degree in Medicine, Pharmacy or Life ScienceDesired:Training/experience in PharmacokineticsMaster’s degree in Clinical trials monitoring or Clinical trials project managementLanguages:Fluent in English required, communicative level in Spanish preferred, knowledge of other languages will be an asset.Experience (years/area):At least 1 years of experience in a similar position.Specific Knowledge:Experience in an environment of Clinical Development, primarily in PK and BE studies:Current knowledge of laws, regulations, and guidance (ICH, EMA, FDA, etc.) related to design and execution of clinical trials, primarily PK and BE studies as well as demonstrating bioequivalence in general.Preparation and review of study documentation.Implementation of trials in global environment.Project management of multiple studies.Travels:Willingness to travel (Personal skills:Ability to work in cross-functional teams in an international environment.Demonstrate organization and planification skills.Ability to manage multiple projects timelines, while maintaining focus on priorities. Easily accommodate changes in plans.Exhibit sense of urgency in execution of tasks.Exhibit curiosity and willingness to learn.Ability to pay attention to relevant details when reviewing documentation and plans.Demonstrate proactive problem-solving capabilities and interpersonal communication skills.COMPROMISO CON LA IGUALDAD DE OPORTUNIDADESEl grupo InsudPharma es consciente que la gestión empresarial tiene que estar en consonancia con las necesidades y demandas de la sociedad, y por ello asume el compromiso de igualdad de oportunidades y trato entre hombres y mujeres, tal y como se recoge en la normativa vigente en la materia -Ley Orgánica 3/2007, y no discriminamos a ninguna persona por motivos de etnia, religión, edad, sexo, nacionalidad, estado civil, orientación afectiva o sexual, identidad o expresión de género, discapacidad, o cualquier otra circunstancia personal o social.