Oncology Global Study Manager

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona - On-Site**

**Temporary position: 6 months + 6 months.**

The Global Study Manager (GSM) is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with the Global Study Director (GSD) / Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

**Typical Accountabilities**:

- In partnership with AZ enablement team, other AZ clinical experts and external serviceproviders, the GSM provides oversight to ensure study delivery.
- Leads/contributes to the preparation of delegated study documents (e.g. InformedConsent Form, master Clinical Study Agreement etc), and external service providerrelated documents (specifications, study specific procedures, descriptions,presentations etc.).
- Maintains and facilitates interactions with internal functions including but not limited toEnablement, Data Management, Procurement, Regulatory, Patient Safety and QualityAssurance, and external functions including the CROs and other external serviceproviders to ensure an efficient study delivery to time, costs and quality objectives.
- Contributes to the planning and conduct of internal and external meetings (e.g.Investigators’/Monitors’ meeting).
- Ensures the supply of Investigational product and study materials by liaising with Clinical SupplyChain or external service providers as appropriate.
- Proactively contributes to risk and issue identification, development of mitigation and/or actionplans for identified risks and issues.
- Ensures that all study documents in scope of GSM’s responsibilities are complete and verifiedfor quality in Trial Master File.
- Supports GSD/GSAD with budget management, such as external service provider invoicereconciliation.
- Adheres to global clinical processes, procedural documents, applicable Quality &Compliance manual documents and international guidelines such as ICH/GCP to ensurestudy is inspection ready at all times.Supports GSADs in project management as per agreed delegation.
- For outsourced studies, supports GSD/GSAD in management of the CRO Project Manager toensure study delivery according to agreed timelines, budget and quality standards, whileensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations).
- Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

**Education, Qualifications, Skills and Experience**

**Essential**:

- University degree (or equivalent),preferably in medical or biological sciences or discipline associated with clinical research.
- Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
- Knowledge of clinical development /drug development process in various phases of development and therapy areas
- Excellent knowledge of international guidelines ICH/GCP
- Excellent communication and relationship building skills, including external service provider management skills
- Good project management skills
- Demonstrated ability to collaborate as well as work independently
- Demonstrated leadership skills
- Computer proficiency, advanced computer skills in day-to-day tasks
- Excellent verbal and written communication in English.

**Desirable**:

- Advanced degree
- Experience in all phases of a clinical study lifecycle
- Basic knowledge of GXP outside of GCP (i.e GMP/GLP)

  • Global Study Manager

    hace 1 mes

    Barcelona, España Morgan Philips Executive Search A tiempo completo

    Important Pharmaceutical Company is looking for a Global Study Manager - Early Oncology Clinical: The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. **Responsabilities**: Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template...

  • Global Study Manager, Oncology R&D, Early Oncology Clinical

    hace 1 mes

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    Location: Barcelona, Spain (on-site) / Able to be office based (3 days per week) in the Barcelona office from day 1. For candidates living in other locations requiring relocation, candidate should be able to relocate and start in the AZ role within 2 months once offer is accepted. AZ will not provide relocation package for this role. The Global Study Manager...

  • Global Study Associate Haematology

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Global Study Associate Haematology** **Location: Barcelona, Spain** When we put unexpected teams in the same room, we fuel ambitious thinking with the poweencouragespire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per...

  • Global Study Manager Biopharmaceuticals

    hace 1 día

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (on-site)** The **Global Study Manager** is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of...

  • Senior Global Study Manager

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (on-site)** The Senior Global Study Manager, Cell Therapy is responsible for leading the operational activities to support and enable the delivery of cell therapy clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the nature of the clinical program or clinical study, so a high degree...

  • Associate Director Study Leader, Oncology R&d

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    The Associate Director Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines. Provides matrix management of functional area representatives to...

  • Global Study Manager Haematology

    hace 2 días

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (On-site)** **Why AstraZeneca?** At AstraZeneca, we are united in our vision to eliminate cancer as a cause of death. We are a science-based, leading and crucial Oncology enterprise, constantly pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the...

  • Director Study Leader, Early Oncology Clinical

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    The Director Study Leader, Early Oncology Clinical is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy...

  • Global Development Scientist Director, Late Oncology

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    **Loction: Barcelona (On-site)** We are looking to hire a Global Development Scientist Director Late Oncology. Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to...

  • Global Development Scientist Director Late Oncology

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science. **About AstraZeneca** AstraZeneca is a global, science-led,...

  • Global Development Medical Director, Late Oncology

    hace 1 mes

    Barcelona, España AstraZeneca A tiempo completo

    **Global Development Medical Director** **About AstraZeneca**: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical...

  • Global Study Associate

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Disability certification of 33% / Certificado de Discapacidad 33%*** **Location**:Barcelona, Spain The Global Study Associate is responsible for supporting the delivery of clinical studies by providing administrative and system support. The Global Study Associate will work across several studies, so a high degree of flexibility is required. The exact...

  • Global Development Medical Director, Late Oncology

    hace 1 mes

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Location: Barcelona (on-site)We are looking for a Global Development Medical Director, Late OncologyDo you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies?Would you like to apply your expertise to impact the way cancer is treated, and make a meaningful difference to patients, in a company...

  • Medical Monitor

    hace 2 semanas

    Barcelona, España Michael Page A tiempo completo

    ¿Dónde vas a trabajar? A Biopharmaceutical company is looking for a Medical Monitor - Oncology ¿Qué harás en tu nuevo puesto? The Medical Monitor collaborates in the overall global (US/EU) clinical development for oncology compounds, taking into consideration both medical and scientific issues. She/he is part of a multi-disciplinary, multi-regional,...

  • Medical Monitor

    hace 2 semanas

    Barcelona, España Page Personnel A tiempo completo

    The candidate must be a hematologist| It is essential that the candidate has worked as a medical monitor or similarA Biopharmaceutical company is looking for a Medical Monitor - OncologyThe Medical Monitor collaborates in the overall global (US/EU) clinical development for oncology compounds, taking into consideration both medical and scientific issues....

  • Global Study Associate Director Haematology

    hace 1 día

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (on-site)** The **Global Study Associate Director (GSAD)** is a business-critical role within Study Management R&D, Development Operations, whose main accountability is the delivery of clinical studies. The **GSAD** is responsible for leading a cross-functional study team (core and extended) and for providing the team with...

  • Director Study Management Haematology

    hace 7 días

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (On-site)** The DSM, is responsible for leading, developing, supporting, and providing direction to Study Management and Operations (SMO) personnel for project, TA/scientific/technical, and operational related issues to enable delivery of drug projects and non drug projects. The DSM is ac countable for resourcing SMO members o...

  • Lead Study Coordinator

    hace 4 semanas

    Barcelona, España Vall d'Hebron Institute of Oncology (VHIO) A tiempo completo

    7 July 2021 **El Vall d´Hebron Institute of Oncology (VHIO) busca un **“Lead Study Coordinator”** **Referència**: 32-2021 **Termini de finalització de la presentació**:31/07/2021 **Nº de places**:1 **Descripció de l’oferta**: Es busca una persona amb per realitzar les següents tasques dintre de la Unitat d’Assaigs Clínics: - Responsable...

  • Global Development Medical Director, Breast Cancer

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Do you have expertise in Oncology clinical drug development and passion for developing late phase clinical program strategies? Then AstraZeneca might be the place for you! **About AstraZeneca** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription...

  • Sr. Global Development Scientist Director Late

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science. **About AstraZeneca** AstraZeneca is a global, science-led,...