Real World Evidence

vor 6 Monaten

Basel, Schweiz Philip Morris International Vollzeit

Real World Evidence (RWE) Study Manager - Neuchatel, Switzerland

Be a part of a revolutionary change.

At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products.

With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.

It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products.

If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future.

Your ‘day to day’

As a Real Word Evidence (RWE) Study Manager you will be responsible for the implementation and execution of assigned RWE studies in humans including study planning, monitoring the progress and management of external and internal partners involved in the study execution. You will contribute to the preparation and review of study related documents (e.g. Study Protocols, Informed Consent Forms, Study Reports, various study plans, such as Project and Risk Management Plan, Operational Study Plan, Quality plan) and will be accountable for the compliance with the study protocols, following the principles of Good Epidemiological Practices (GEP), and in strict adherence to PMI's Standard Operating Procedures (SOPs), Work Instructions (WKIs) and applicable laws and regulations. You will be responsible for the oversight of the Clinical Research Organizations (CROs) and to ensure the study is carried out as per agreed budget and timelines.

RWE studies may cover various types of studies including but not limited to cohort, cross-sectional, registry, epidemiology, observational studies.

If required, you may also assist or be responsible for the implementation and execution of clinical studies following ICH-GCP principles.

This position requires worldwide traveling.

More specifically, you'll
- Be accountable for overseeing all study related activities throughout the entire study duration, including planning of activities, risk mitigation strategies, monitoring of the progress and coordination and supervision of the CROs, investigational sites (if any), laboratories (if any) and others externally/internally involved in the study execution. Lead the Study Teams and all operational aspects of assigned RWE or Clinical studies. Parallel management of lower complexity studies (e.g., registries studies) at various stages of execution or parallel management of more complex studies including ICH-GCP studies.
- Ensure timely delivery of study related documents such as Investigator Brochure, Protocol Outlines, Protocols, Informed Consent Forms, Diaries, Case Record Forms, Study Report etc. For documents generated by external parties ensures timely delivery and reviews of such documents. Contribute to above mentioned documents (input, reviews, quality checks). Accountable for the collection of essential documents and completeness of Trial Master Files. Contribute to the Quality Control of all deliverables received from CROs.
- Be responsible for the review and approval of the Regulatory Authorities and Ethics Committee submission packages (as applicable) and for the preparation of the relevant study plans as per PMI WKIs (e.g.: Project Management Plan, Communication Plan). Contributes to the review of the RWE Operational Plan/ Quality Plan.
- Ensure that studies are carried out according to PMI's SOPs and WKIs, following the applicable principles (e.g.: GEP, ICH GCP), Declaration of Helsinki and with strict adherence to any applicable laws and regulations. Ensure that any compliance issues are raised to Quality Assurance (QA), supervisor and the relevant leadership team and ensures that necessary corrective and preventive actions are put in place.
- Track the progress of activities contracted out to external vendors and investigators (if applicable) and ensure their completion according to defined quality, timelines, and costs. Closely collaborate with budget leads in the management of study budgets and change orders, and report status and progress to management and relevant functions in project-based organization.
- Participate to the selection process of CROs (including site pre-selection visits if applicable), participation to bid defense meetings and assessment of CROs’ proposals. Provide operational recommendations to Clinical Operations Management, Procurement, and Medical Research/RWE members participating to the selection process. Contribute to the review of the project agreement(s).
- Maintain up-to date knowledge of GEPs, GCPs and relevant other

  • Senior Evidence Strategist

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    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.Medical Evidence Practice TeamThe Medical Evidence Practice...

  • Senior Real-World Evidence Strategist

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    IQVIA, the Human Data Science Company, is dedicated to harnessing data and science to empower healthcare clients in their pursuit of better solutions for patients.The Medical Evidence Practice (MEP) team plays a crucial role in designing and delivering innovative, technology-enabled evidence programs for the pharmaceutical industry. By applying scientific...

  • Director of Real-World Evidence Strategy

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    About the RoleWe are seeking a highly skilled Principal to join our Medical Evidence Practice team in Switzerland. As a Principal, you will play a key role in designing and delivering innovative, technology-enabled evidence programs for the pharmaceutical industry.As a member of our team, you will apply scientific rigor and advanced analytics to real-world...

  • Principal - Real-world Evidence Consulting

    vor 3 Wochen

    Basel, Schweiz IQVIA Vollzeit

    **_This position is advertised in many locations for visibility but available only in Switzerland._** IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics...

  • Principal - Real-World Evidence Strategist - Switzerland

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    About the RoleAs a Principal within the Medical Evidence Practice (MEP) team at IQVIA, you will take on a variety of roles within the following core areas: business development, client relationship building, project leadership, and team development.Key ResponsibilitiesMeet or exceed assigned sales targets by consulting with clients to fully understand their...

  • Real World Evidence Consultant

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    Unlock New Horizons in Real-World Evidence ConsultingIQVIA is a trailblazer in the life sciences industry, harnessing data and science to revolutionize healthcare. As Principal - Real-World Evidence Consulting - Switzerland, you will be at the forefront of our journey, shaping the future of medical evidence.About the RoleWe are seeking an exceptional leader...

  • \"Principal - Real-World Evidence Consultant - Switzerland\"

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz IQVIA Vollzeit

    About the RoleIQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. As a Principal within the Medical Evidence Practice (MEP) team, you will take on a variety of roles within the following core areas: business development, client relationship building, project...

  • Principal - Real-World Evidence Consulting - Switzerland

    vor 5 Monaten

    Basel, Schweiz IQVIA Vollzeit

    IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Medical Evidence Practice team (MEP) As the...

  • Principal - Real World Evidence Consulting

    vor 6 Monaten

    Basel, Schweiz Novasyte Vollzeit

    IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Medical Evidence Practice Team Our work can be complex...

  • Principal - Real World Evidence Consulting

    vor 6 Monaten

    Basel, Schweiz IQVIA Vollzeit

    IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. **Medical Evidence Practice Team** Our work can be...

  • Team Manager, Epidemiology and Real-world Evidence

    vor 5 Monaten

    Basel, Schweiz Philip Morris International Vollzeit

    Team Manager, Epidemiology and Real-World Evidence (RWE) - Neuchatel, Switzerland Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom...

  • Real-world Data Adoption Lead

    vor 3 Monaten

    Basel, Schweiz ITech Consult Vollzeit

    **Project**: For our customer a big pharmaceutical company in Basel we are looking Real-World Data Adoption Lead (M/F/d). **Background**: The position will play a pivotal role in advancing the Diagnostic’s utilization of Real World Data (RWD), unlocking its potential for data-driven decision-making. The Adoption Lead will be responsible for designing and...

  • Real-world Data Adoption Lead

    vor 3 Monaten

    Basel, Schweiz FLEXSIS Vollzeit

    **INTRODUCTION**: As a preferred supplier for Roche Basel, we are looking for an individual as **Real-World Data Adoption Lead**: with a 12-month contract and possibility to extend. The earliest start date is within 2-3 months or asap. Home Office will be possible. Gross target annual salary will be around 130'000 - 145'000 CHF depending on...

  • Head of Global Medical

    vor 2 Wochen

    Basel, Schweiz Bayer Vollzeit

    **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...

  • Associate Principal

    vor 1 Tag

    Basel, Schweiz IQVIA Vollzeit

    This role is available anywhere in Europe. If your preferred location is not listed, please add the information to your CV._ **Real-World Solutions, Payer Evidence Solutions** Our Payer Evidence Solutions practice helps our customers design and execute an evidence generation strategy meeting payer and health technology assessment (HTA) evidence...

  • Medical Evidence

    vor 5 Monaten

    Basel, Schweiz Neurocrine Bioscience Vollzeit

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options. What We Do: Neurocrine Biosciences...

  • Head of Global Medical

    vor 1 Woche

    Basel, Schweiz Bayer (Schweiz) AG Vollzeit

    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...

  • Associate Director Rwe

    vor 2 Wochen

    Basel, Schweiz Datalynx AG Vollzeit

    For our client, a well-known pharmaceutical company in Basel, we are looking for an Associate Director RWE (M/F/d). **Background** We are looking for an experienced Associate Director RWE & Innovative Evidence to join our team. You will play a crucial role in developing, supporting, and implementing evidence strategies that inform business decisions and...

  • Access Evidence Chapter Lead

    vor 1 Monat

    Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Access Evidence Chapter Lead

    vor 1 Monat

    Basel, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...