Real World Evidence (RWE) Study Manager

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. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. 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 regulations. Responsible for development and maintenance of assigned SOPs, WKIs and document templates. Provide recommendations for the process improvements and/or implementation of new processes for quality/efficiency improvements. • If any Investigational Site is involved, be responsible for strict supervision of monitoring activities including definition of monitoring plans, review of monitoring reports, follow-up letters. Responsible for planning and performing co-monitoring visits to assess sites and monitors performance. Who we’re looking for • College/University Scientific degree (e.g.: MD, PharmD or PhD) in the life science domain and/or equivalent skills through demonstrated experience. • Demonstrated experience in management of the RWE studies in a pharmaceutical company or a CRO. • Previous experience in management of clinical studies is an asset. • Strong CRO oversight experience. • Previous experience in Quality Assurance. / Quality Control is an asset. • Previous expertise in implementing studies in the USA and /or Japan is an asset. • Good knowledge of ICH GCP and methodology of execution and monitoring of clinical studies as well as of GEP and overall RWE methodologies. • Good project management skills including use of tools such as MS Project. • Good MS Office skills. • Working knowledge of electronic Trial Master Files (e.g., Veeva Vault). • Excellent communication and interpersonal skills with strong influencing abilities. • Fluent in English, both written and spoken, knowledge of other languages is an asset. What we offer Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: a smoke-free future. #LI-Hybrid