Clinical Data Scientist 1

hace 5 meses

Girona, España Almirall A tiempo completo

Mission

Based on best international practices, capture, integrate and store clinical trials information (data and documents) to allow on-going data analysis and results reporting to access efficiently to clinical data of our medicinal products and to allow a shorter decision making process. 

Tasks and Responsibilities

 Responsible for performing the necessary internal processes and overviewing CRO activities for adherence to the applicable data standards, quality and timelines, following Good Clinical Data Management Practices and applicable Clinical Trials Regulations, like FDA, EMA, ICH. Review the protocol for adherence to Almirall Data Management processes and Data Standards.  Lead the review and approval electronic Case Report Form (eCRF), eletrconic Patient Reporting Outcomes (ePRO) and its corresponding completion guidelines. Management of any data finding or/and processes during trial conduction that implies changes in the standards/processes in alignment with the responsible lead of coordinating these standards.  Set-up: Review annotated documents, Data Management Plan (coding, validation plan, SAE reconciliation between safety and clinical databases) vendor’s technical specifications (from DM perspective)  Conduct: Manage with the CRO in order to have data available for data visualization and analysis at the agreed milestones established at contract level. Assessment of the database structure and study documentation review, evaluation of the data quality in on-going basis. Coordination of Almirall data review activities and follow-up or finding resolution with CRO.  Closure: Management of the database lock processes, review related database lock documentation (including approval of coding and SAE reconciliation), evaluation of the database quality (minimum requirements) before database lock approval to warrantee Almirall requirements.  Provision to CROs of the necessary documentation to perform the outsourced activities according to Almirall standards processes and expectations.  Follow-up on target and metrics indicators for overseeing quality and deliverables of CRO Data Management activities.  Participation together with the Q&A department in the inspections derived from the clinical trial.  Provide technical advice on Data Management methodologies and processes to other departments or areas of R&D and the company who requires it.  Analysis and assessment of new standards, systems and processes. Collaboration in implementation and development of new technologies. Meeting with external assessors & regulatory authorities when required. Participation in Data Management Associations, trainings and Congresses, national and international, related to Data Management and Clinical Development methodology and techniques, with the objective of warranting the continuous training and regular update of the required knowledge. Working with Partners in different projects

Education

Bachelor degree in Statistics, Mathematics, Life and Health Science (Pharmacy, Veterinary, Medicine, Biology), IT or Degree with specific experience in the Job. 

Experience

2+ years of experience as Clinical Data Scientist or Data Manager in the Pharma industry or a CRO. 

Working knowledge of CDSIC (SDTM standards). 

Clinical trials. 

Project Management and planning experience. 

Excellent English communication skills (written and spoken) across different levels within the organization. 

Values and competencies

•  Care:  we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
•  Courage:  we challenge the status quo, we take full ownership and we learn from our success & failures
•  Innovation:  we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
•  Simplicity:  we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.

  • Lead Clinical Scientist, Research and Development

    hace 1 semana

    Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About Daiichi Sankyo EuropeDedicated to discovering, developing, and delivering innovative treatments that enhance the quality of life for patients worldwide, Daiichi Sankyo Europe is a leader in the pharmaceutical industry. With over 120 years of experience and a global presence in more than 20 countries, our team of experts strives to push the boundaries...

  • Senior Manager, Clinical Scientist

    hace 3 semanas

    Girona, España buscojobs España A tiempo completo

    Senior Manager, Clinical Scientist (m/f/x)Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The...

  • Senior Manager, Clinical Scientist

    hace 3 semanas

    Girona, España buscojobs España A tiempo completo

    Senior Manager, Clinical Scientist (m/f/x)Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The...

  • Director of Clinical Development and Operations

    hace 6 días

    Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About Daiichi Sankyo EuropeWith over 120 years of experience, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, where we have affiliates in 13 European countries and Canada.Job OverviewWe are seeking a highly...

  • Global Clinical Program Lead

    hace 7 meses

    Girona, España Almirall A tiempo completo

    Mission • The Global Clinical Program Lead (GCPL) is a core member of the Global Project Team and is leading the Strategic Clinical Team within Global Clinical Development, working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs,...

  • ADME & DMPK Senior Scientist

    hace 6 meses

    Girona, España Almirall A tiempo completo

    Mission Be a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.  Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related...

  • Data Analyst

    hace 6 meses

    Girona, España Setesca Talent A tiempo completo

    Descripción Desde Setesca estamos seleccionando un/a DATA ANALYST, para incorporarse directyamente en plantilla de una empresa multinacional del sector transporte/logistico. **FUNCIONES**: 1. Creación de la plataforma data y analítica de la compañía en tecnología Azure, conectando las diferentes fuentes de datos y aplicaciones de negocio y creando...

  • Business Controller R&D 1 1

    hace 7 meses

    Girona, España Almirall A tiempo completo

    Misión Responsible for the control of the business unit/area/site in R&D, guaranteeing the correct follow-up and financial support, participating in the decision-making of the area/business. Funciones y responsabilidades Monitoring and improving the internal control processes assuring the consistence and the validation of the financial...

  • Principal Investigator

    hace 7 meses

    Girona, España Almirall A tiempo completo

    Mission Almirall is a global pharmaceutical company with a focus on Medical Dermatology. Our goal is to develop novel therapeutic drugs to treat a wide range of dermatological conditions and improve the quality of life for millions of patients worldwide. As such our Research & Development team, based in Barcelona, is looking for a highly motivated...

  • Statistical Programming Lead

    hace 5 días

    Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo

    We are seeking a skilled Statistical Programming Lead to join our team at Daiichi Sankyo Europe.About UsDaiichi Sankyo is a global pharmaceutical company dedicated to developing innovative treatments for patients around the world.Salary Range: €70,000 - €90,000 per yearJob Description:The Statistical Programming Lead will be responsible for managing and...

  • Associate Director, IT DELIVERY AREAR&D

    hace 6 meses

    Girona, España Almirall A tiempo completo

    Mission The main mission is to lead and execute strategic IT programs that improve the capabilities and performance of R&D, using the own Service Delivery team or coordinating resources from the associated IT department and external partners. In addition, it seeks to integrate business processes leveraging existing and new technology to meet specific...

  • Gestor/ de Dades

    hace 6 meses

    Girona, España Ajuntament de Girona A tiempo completo

    Característiques de l'oferta**Estat de l'oferta**: Oberta **Nombre de places**: 1 **Jornada laboral**: Intensiu **Horari**: Horari intensiu de 8:00 a 15:00h, de dilluns a divendres. **Població**: Girona **Tipus de contracte**: Indefinit: ordinari **Sou orientatiu**: Salari segons conveni col-lectiu de l'empresa i categoria laboral (a partir de...

  • Manager Statistical Programming

    hace 3 semanas

    Girona, España buscojobs España A tiempo completo

    Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas : The goal of our Specialty Business is to protect...

  • Manager Statistical Programming

    hace 3 semanas

    Girona, España buscojobs España A tiempo completo

    Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas : The goal of our Specialty Business is to protect...

  • Coordinador/a d'Activitats Recreatives

    hace 9 horas

    Girona, Gerona, España Consell Comarcal De La Selva A tiempo completo

    Empresa dedicada a la prestació de serveis esportius busca incorporar un professional per treballar al seu equip a Riudarenes. El lloc de treball és el gimnàs i les condicions laborals inclouen una jornada laboral de 13 hores setmanals amb horari flexible. Condicions laborals: * Contracte: indefinit. * Horari: a determinar. * Salari: 512 €/mes...

  • Accountant Trainee Girona

    hace 6 meses

    Girona, España fundcraft A tiempo completo

    About fundcraft fundcraft is a fast-growing start-up, aiming to revolutionise the fund management industry through our proprietary platform. We’re building the digital infrastructure for asset managers. Our dedicated team of financial experts, lawyers, tech developers, and data scientists are fully committed to turning the organisation to a leading fund...

  • Accountant Trainee Girona

    hace 4 días

    Girona, España fundcraft A tiempo completo

    About fundcraftfundcraft is a fast-growing start-up, aiming to revolutionise the fund management industry through our proprietary platform. We’re building the digital infrastructure for asset managers. Our dedicated team of financial experts, lawyers, tech developers, and data scientists are fully committed to turning the organisation to a leading fund...

  • Administrador/a de Serveis de DAI

    hace 2 meses

    Girona, Gerona, España Intress A tiempo completo

    Funcions del LlocInters forma part d'una gran entitat que creu en la integració de les persones que es troben en situació de vulnerabilitat social. Com a Auxiliar administratiu/va, formarà part del nostre servei del DAI (Dispositiu d'Atenció Immediata per joves migrats sols al territori), ubicat a la zona del Maresme, concretament a Canyamars, Dosrius.El...

  • Treballador/a d'Atenció al Client i Pressupostos

    hace 7 días

    Girona, Gerona, España Alzamora Packaging A tiempo completo

    Alzamora Grup és una de les companyies lïders en el sector del packaging de cartó. La innovació permanent i la inversió en el desenvolupament professional dels nostres equips ens ha permès expandir-nos nacionalment i internacionalment. Estem cercant un/a treballador/a d'atenció al client i pressupostos per ocupar aquest lloc a la nostra fàbrica...

  • Sr. Manager, Sales Motions

    hace 2 meses

    Girona, España Databricks A tiempo completo

    Sr. Manager, Sales Motions & Productivity GironaSLSQ425R477What You Will DoWe are seeking a highly accomplished individual to join our dynamic organization as the Sr Manager, Sales Motions & Productivity. As a key member of the Central Global Sales Strategy team, the successful candidate will play a critical role in driving increased sales productivity and...