Clinical Trials Quality Assurance Manager

hace 3 semanas


Madrid, España Sdi Digital Group A tiempo completo

Job Overview Review & approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for medium / high-risk / complex quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
Perform Quality Event management within QA-CAPA Center Of Excellence, responsible for processing / supporting :
Customer audits and regulatory inspectionsQuality issue and query escalations to QAProvide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions as applicable and / or required : Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations / guidelines, customer requirements, IQVIA SOPs and project specific guidelines / instructionsEvaluate audit findings and prepare and distribute reports to operations staff, management, and customersProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and proceduresProvide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plansManage Quality IssuesPresent educational programs and provide guidance to operational staff on compliance proceduresReview, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activitiesProvide quality assurance consultancy activities and projects for clients within budget and established timelinesEvaluate policies and procedures for compliance with applicable regulations / guidelines and provide recommendations to management for continuous process improvementsManage / oversee quality events updates in eQMS and / or Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycleLead / collaborate / support in QA initiatives / projects for quality, process improvementsAssist in training of new Quality Assurance staffQualifications Bachelor's Degree Pref5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GCP and Clinical Trial experience.Equivalent combination of education, training and experience.
Knowledge of word-processing, spreadsheet, and database applications..Extensive knowledge of pharmaceutical / Clinical research and development processes and regulatory environments..Knowledge of quality assurance processes and procedures..Strong interpersonal skills..Excellent problem solving, risk analysis and negotiation skills..Strong training capabilities..Effective organization, communication, and team orientation skills..Ability to initiate assigned tasks and to work independently..Ability to manage multiple projects..Ability to establish and maintain effective working relationships with coworkers, managers and clients.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at

#J-18808-Ljbffr


  • General practitioner

    hace 4 semanas


    Madrid, España Affidea A tiempo completo

    We are looking for General Practitioners or Physicians for our clinics around Europe.These profiles will be in charge of clinical trials as principals, and therefore experience in this field is required.Minimum of two years as a Principal during clinical trials.Minimum of two completed clinical trials as Principal.


  • Madrid, España ICON A tiempo completo

    As a Clinical Quality Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Under the guidance of the Regional Director, Clinical Quality Management, the Clinical Quality Manager oversees all CQM activities in the respective country/cluster. The role requires the ability...

  • General Practitioner

    hace 3 semanas


    Madrid, España Affidea Group A tiempo completo

    We are looking for General Practitioners or Physicians for our clinics around Europe. These profiles will be in charge of clinical trials as principals, and therefore experience in this field is required. Minimum of two years as a Principal during clinical trials.Minimum of two completed clinical trials as Principal. #J-18808-Ljbffr


  • Madrid, España Sdi Digital Group A tiempo completo

    Job Overview Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and / or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and...


  • Madrid, España Fortrea - Organic A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Quality Assurance Manager

    hace 2 semanas


    Madrid, España Simplekyc A tiempo completo

    Simple KYC is a fast-growing Australian startup working with banks to develop innovate technology solutions that help them automate 'Know Your Customer', 'Anti Money Laundering', 'Due Diligence' and 'Customer Onboarding' processes. We make data easy to visualize, analyze and interact with. We work with industry-leading clients such as American Express, ANZ,...


  • Madrid, España ICON A tiempo completo

    **Clinical Research Physician** **Alcobendas, Madrid, Spain - Part-time, 3 days a week ONSITE** Are you looking for an outstanding opportunity to develop your career with a fast growing leading edge Clinical research company and to be involved in the future of medicine across the globe ? Accellacare concentrates on phase 2, 3 and 4 clinical trials...

  • Quality Manager

    hace 2 semanas


    Madrid, Madrid, España IQVIA A tiempo completo

    Job OverviewThis role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the...


  • Madrid, España AbbVie A tiempo completo

    **Company Description** **Job Description** SMA III** As a Clinical Trial Manager, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Clinical Trial Manager works as an independent, contributing member of a cross-functional and global...

  • Quality Manager

    hace 2 semanas


    Madrid, España IQVIA A tiempo completo

    Job Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the...


  • Madrid, España Oracle A tiempo completo

    Clinical Project Manager-230003CJ **Applicants are required to read, write, and speak the following languages***: English, Spanish **Preferred Qualifications** Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies....


  • Madrid, España Psi A tiempo completo

    Job DescriptionYou will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors. You willReview external vendor quotationsMaintain vendor databases and tracking systemsSupport vendor identification, assessment...


  • Madrid, España Psi Cro A tiempo completo

    Job Description You will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors.  You will Review external vendor quotations Maintain vendor databases and tracking systems Support vendor identification,...


  • Madrid, España Novo Nordisk A tiempo completo

    Clinical Medical Manager **Category**:Medical Affairs**Location**:Madrid, Comunidad de Madrid, ES- **The position** - As Clinical Medical Manager, on interactions with KOLs, independent professional associations and patient advocacy associations as necessary.- - Identify and map KOLs, investigators and research centres within the relevant therapy areas and...


  • Madrid, España PSI CRO A tiempo completo

    Job DescriptionYou will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors. You willReview external vendor quotationsMaintain vendor databases and tracking systemsSupport vendor identification, assessment...


  • Madrid, España PSI A tiempo completo

    Job Description You will be responsible for supporting the establishment of approaches, processes and information flow, along with building strong relationships to ensure effective collaboration between PSI teams and PSI vendors.  You will Review external vendor quotations Maintain vendor databases and tracking systems Support vendor...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...


  • Madrid, España Accedo Tv A tiempo completo

    The multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV, Android TV, Chromecast, Web, Smart phones, tablets and more. Accedo is a leading company in this sector and is hiring at multiple locations (Madrid,...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** Experience in the management of global/multi-country studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based - Spain/Italy/Portugal** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead...