Clinical Study Excellence Scientist

hace 7 días


Barcelona, España Bayer (Schweiz) Ag A tiempo completo

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility.
We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'.
There are so many reasons to join us.
If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Clinical Study Excellence Scientist Purpose: The Clinical Study Excellence Scientist (CSES) is the point of contact and responsibility for all aspects of a trial within the study team, with the aim of ensuring the safety of study participants, the quality of data and the success of the development project.
As a member of the Global Clinical Sub-Team (GCT), the CSES will support the GCT with expert knowledge and insight into the study.
Scope: Global Key Responsibilities: Primary contact person during the study for protocol and safety questions for one or more trials (for which he / she has as an in-depth understanding of protocols and protocol requirements) Responsible for designing the medical review strategy and developing the Medical Review Plan Contribute to the content of sections of clinical study protocol and other study-related documents/publications that require scientific input, in collaboration with the GCL and other relevant functions (including but not limited to ICF, eCRF, CSR, Narratives, IB, DSUR).
Provides input into eCRF development and participates in eCRF user acceptance testing (UAT) and final approval of the eCRF.
Understands the asset's biological mechanism, clinical strategy, safety profile, scientific interpretation of disease, and target-based literature.
Provides medical input at SIV and Investigator Meetings and in collaboration with the GCL may present the medical background, rationale for the trial and relevant sections of the protocol.
Supports the Clinical Lead for the presentation of clinical/safety data to DMC, SCs, internal governance committees and external consultants.
Trains or contributes to the training of study team, CRAs/CLMs, site staff and CRO staff (if applicable) on medical aspects of the study, indication, and compound.
Queries identifiable safety-related medical discrepancies or requests for clarification in the appropriate EDC and related systems.
Coordinates with Clinical Lead to provide consistent replies to health authorities, including local Ethics committees (ECs) Reviews incoming medical data, on both accumulative and individual basis.
Develops a safety aggregated report periodically for cross-functional review with specific attention to Adverse Events [Treatment-Emergent Adverse Events (TEAE), Related TEAE], Treatment-Emergent Serious Adverse Events (TESAE), Adverse Events of Special Interest (AESI), worst Post-Baseline Laboratory Shift Tables, Study Status, Summary Table, AE Summary, SAE Summary Supports medical protocol deviations cross-functional review, as appropriate.
Contributes to the conduct of study feasibility assessments.
Collaborates effectively with study team on study deliverables, as appropriate.
Contributes to the selection of vendors for the outsourcing of clinical trial services.
Supports the coding of reported terms for medical history, concomitant medications, and adverse events.
Value added: The CSES ensures the safety of study participants, the quality of data and an optimal development of the Investigational Medicinal Product.
Work interactions: Core Study Team Global Clinical Lead / Clinical Development Lead/ Early Clinical Lead Global Safety Lead Data Monitoring Committee / Steering Committee/ Adjudication Committee/ External Experts Country Lead Monitor / Clinical Research Associate Qualifications: MD, DO, PhD, PharmD, RN with 3-5 years of clinical trial scientist experience (or equivalent).
Fluent in English, both written and spoken.
Collaborative and team-oriented worker.
Sensitive to diverse global cultures.
Strong communicator for both scientific discussions and study center training.
WHAT WE OFFER: Guided by our mission 'Health for all, Hunger for none', we deliver breakthrough innovations in healthcare and agriculture.
If you're looking to build a meaningful career in a community of creative and diverse people dedicated to making a difference, join us
We offer you: Flexible & hybrid work model.
Career development & learning opportunities.
Work-life balance for your physical & mental wellbeing.
Competitive salaries & financial wellbeing (e.g.
life insurance).
We promote employee's well-being, Inclusion & diversity and sustainability in a collaborative and innovative environment.
We promote social engagement through our volunteering program.
YOUR APPLICATION: This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change.
You have a voice, ideas and perspectives and we want to hear them.
Because our success begins with you.
Be part of something big.
Be Bayer.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
We are committed to treating all applicants fairly and avoiding discrimination.
Location: Spain : Cataluña : Barcelona Division: Pharmaceuticals Reference Code: 822648 #J-18808-Ljbffr



  • Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    .At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities...


  • Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    .At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities...


  • Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Barcelona, España Bayer A tiempo completo

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Barcelona, España Bayer (Schweiz) AG A tiempo completo

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Barcelona, España Bayer (Schweiz) AG A tiempo completo

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Barcelona, España Bayer (Schweiz) AG A tiempo completo

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    About BayerBayer (Schweiz) Ag is a leading global healthcare company committed to developing innovative products that improve human health and quality of life.As a Clinical Study Excellence Scientist at Bayer, you will play a crucial role in ensuring the safety of study participants, the quality of data, and the success of our development projects.Job...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (On-site). 3 days working from the office and 2 days working from home.** **Role Description** The Director Scientist is an important part of the Project Team, working synergistically with program and study level clinical lead/study physician as the expert in medical scientific aspects of the compound and its development. The...

  • Clinical Scientist

    hace 1 mes


    Barcelona, España Grifols A tiempo completo

    ¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y...


  • Barcelona, España AstraZeneca A tiempo completo

    **Director Clinical Scientist - Hematology Early Oncology R&D*** **Locations flexible: US: San Francisco, CA Gaithersburg, MD, Waltham, MA** **Barcelona, Spain or Mississauga, CN** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits...

  • Clinical Study Expert

    hace 9 horas


    Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    Job DescriptionThe Clinical Study Expert is a key role within Bayer (Schweiz) Ag, responsible for ensuring the safety of study participants, the quality of data, and the success of development projects. As a member of the Global Clinical Sub-Team, this expert will provide expert knowledge and insight into clinical studies.


  • Barcelona, España AstraZeneca A tiempo completo

    **This opportunity is available at our Gaithersburg, MD, Waltham, MA, (USA), Barcelona (Spain) or Mississauga (Canada) locations.** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms...


  • Barcelona, España AstraZeneca A tiempo completo

    **_This opportunity is available at our R&D HUB in Barcelona_** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response,...


  • Barcelona, España AstraZeneca A tiempo completo

    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 companies. AstraZeneca has a multifaceted environment that cultivates...


  • Barcelona, España AstraZeneca A tiempo completo

    **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 companies. AstraZeneca has a multifaceted environment...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Clinical Study Administrator The Clinical Study Administrator (CSA) plays a crucial role in the coordination and administration of study activities from start-up to execution and close-out. Working within the Local Study Team (LST), the CSA ensures the quality and consistency of interventional study deliverables, meeting time, cost, and quality...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (on-site)** The Global Development Scientist Director will provide scientific and clinical input to all aspects of product development for r Vaccines and Immune Therapies assets. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall...

  • Clinical Study Manager

    hace 6 meses


    Barcelona, España Veranex, Inc. A tiempo completo

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...