Senior Manager Rdq Clinical Auditing

hace 1 semana


Madrid, España Bristol Myers Squibb A tiempo completo

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.

**Position Summary**

Conduct Good Clinical Practice (GCP) audits of clinical investigator sites, vendors, internal systems/processes, and pre-qualification audits. Act as an expert in specific GCP related areas, co-investigate alleged cases of scientific misconduct and may coordinate local and major Health Authority Inspections. Represent RDQ-CTQA on due diligence activities for vendors.

**Position responsibilities**
- Perform GCP audits of clinical investigator sites, vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (may function as a lead auditor for wide range of audit types)
- Act as an expert resource for a certain GCP topic within RDQ-CTQA and may function as SME (providing advice and counsel) for the concerned area for the development of SOPs (QA and stakeholder-based) and delivery of training to auditors in the area of expertise
- Lead and/or participate into GPS and/or BMS company processes and improvement initiatives
- Support other areas within RDQ in the creation and maintenance of project/study audit plans; prior to and post audits by sharing newly identified risks to be explored in future audits.
- May assist/coordinate local and major markets HA inspections
- Represent RDQ-CTQA position during internal meetings
- Perform peer audit report review as required
- Represent department on due diligence activities for vendors
- Co-Investigate alleged cases of scientific misconduct or corporate compliance R&D related investigations as assigned

**Experience requirements**
- Profound demonstrated working knowledge of principles and concepts of QA including those related to QRM and Critical Thinking
- Profound GCP wide range of auditing skills including audits at vendors, systems supporting clinical trials as well as profound inspection coordination skills
- Profound knowledge of ICH-GCP guidelines and working knowledge of GxP Guidelines/regulations.
- Profound understanding of the drug development process and regulatory environment
- Profound knowledge of other disciplines in stakeholder’s organizations to influence and support improvements in products, processes and services
- Minimum of 4 years in clinical QA auditing and / or 6 years of work experience in clinical research and/or GCP related QA environment

**Key competency requirements**
- Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for GCP audit findings or issues consistent with company policy, regulatory references and business strategy.
- Excellent oral and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
- Excellent negotiation and influencing skills collaborate effectively with cross-functional team members
- Fluent in English and other languages as applicable to assigned region of responsibility
- Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment

**Travel required (nature and frequency)**
- Approximately 25% travel to perform audits and attend professional meetings and seminars.
- Approximately 5 overnight absences per month

Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.



  • Madrid, España Talent Source A tiempo completo

    Description: **Location**: Barcelona, Madrid, Spain - home based **Schedule**: Freelance - 1 FTE Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it is the best of both worlds. TalentSource Life Sciences (the...

  • Senior Site Manager

    hace 2 días


    Madrid, España Johnson & Johnson A tiempo completo

    **Senior Site Manager, Early Development & Clinical Pharmacology**: We are looking for a Senior Site Manager, Early Development & Clinical Pharmacology (ED&CP) to serve as the primary contact point between the Sponsor and the Investigational Site for the conduct of complex early development and/or clinical pharmacology studies. In other organisations, the...

  • Senior Clinical Research Associate

    Encontrado en: Talent ES C2 - hace 2 semanas


    Madrid, España Worldwide Clinical Trials A tiempo completo

    Requisition Number: 7739 Position Title: Senior Clinical Research Associate External Description: Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications –...


  • Madrid, España EastHORN Clinical Services A tiempo completo

    **Job summary**: As a **Clinical Project Administrator, **you will be expected to provide clerical support to project team and assist in project management activities working with Project Managers. You will be involved in key activities, such as collecting and submitting documents to Regulatory Authorities and Ethics Committees. Additionally, you will be...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Global Clinical Trial Manager **HOMEBASED MADRID ** - Sponsor Dedicated** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **BARCELONA ** - Sponsor Dedicated** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II / Sr CTM - Spain or UK Home-Based** **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 with a...


  • 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 Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **SPAIN ** - Sponsor Dedicated** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed...


  • Madrid, España Kerry A tiempo completo

    **About Kerry**: - Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of...


  • Madrid, España Fortrea 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...

  • Project Manager Ii

    hace 2 semanas


    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Project Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...


  • Madrid, España NonStop Consulting A tiempo completo

    Tengo un par de vacantes como Senior CRA en CRO donde aceptan CRA que no tienen experiência en CRO, este es el rol perfecto para aquellos que estéis trabajando en fundaciones u hospitales y queráis dar el paso e ir a CRO. La empresa ofrece un salario muy competitivo junto con beneficios e incluso una bonificación anual. Buscan a gente para trabajar...


  • Madrid, España Resourcing Life Science A tiempo completo

    **Company Description** Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Contract Manager office based in Madrid. **Job Overview** - Management of the...

  • Senior Field Clinical Specialist

    Encontrado en: beBee jobs ES - hace 1 semana


    Madrid, Madrid, España Abbott Laboratories A tiempo completo

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial...

  • Cdc Clinical Quality

    hace 3 días


    Madrid, España Novo Nordisk A tiempo completo

    CDC Clinical Quality & Training Manager **Category**:Quality**Location**:Madrid, Comunidad de Madrid, ES- Are you passionate about Clinical Trials and looking for a challenge in a Leadership Team?- Do you want to be part of our Clinical Development Centre (CDC) team, integrated by Spain and Portugal?- - The position would be based in Spain.**The...

  • Contracts Manager/ Senior Contracts Manager

    Encontrado en: Talent ES C2 - hace 2 semanas


    Madrid, España Precision Medicine Group A tiempo completo

    We are seeking an accomplished Contracts Manager/ Senior Contracts Manager (clinical trial site agreements) who has direct US/CAN negotiation experience to join our team!We are looking for candidates who have strong experience in Clinical Site Agreements, in particular experience in managing site agreements including the US/CAN.This is a remote based...

  • Senior Clinical Informaticist

    Encontrado en: Talent ES C2 - hace 3 semanas


    Madrid, España Roche A tiempo completo

    The Position MISSION As a Clinical Informaticist, you will work with an interdisciplinary team to collaborate and produce solutions surrounding real world data. Leverage your clinical and domain knowledge to augment business analysis and provide feedback that includes clinical context/workflow in mind. Bridge the gap between IT teams and a deep...


  • Madrid, España Werfenlife Sa. A tiempo completo

    This position it's intended for a person with broad skills in the most used and well known biotechnology techniques, as well as knowledge of the market trends and the latest technology updates. Whithin the Life Science department, the individual will contribute in the implementation and growth of specific business lines, specially in the area of Clinical...


  • Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Principal/Senior Medical Writer** 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...