Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

52010106

Clinical 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 Clinical Study Manager you will coordinate the execution of the assigned clinical studies, lead the Clinical Study Team and all operational aspects of the study including supervision of the CROs (Clinical Research Organization), investigational sites, laboratories and others externally/internally involved in the study execution. More specifically, you'll • Coordinate the preparation of the study related documents, (including but not limited to Protocol Outlines, Protocols, Informed Consent Forms, Diaries Case Record Forms, Report etc.) and for documents generated by external parties ensure timely delivery, reviews and approvals of such documents, as well as contribute to above mentioned documents (input, reviews, quality checks). • Supervise monitoring activities including contribution to the plans, review of reports, follow-up letters and co-monitoring visits, ensure that studies are carried out with full adherence to ICH GCP, Declaration of Helsinki and any relevant standards and regulations. • Support other Clinical Study Managers in execution activities (review of documents, co-monitoring, review of planning / budgets, back-up when needed etc.), participate to the Request for Proposal (RFP) and selection process of the CROs including contribution to RFP documents, review of proposals, participation to bid defense meetings and scoring of proposals. • Track the progress of activities contracted out to providers and investigators, ensuring their completion according to defined quality, timelines and costs, review of budgets, invoices and agreements in close collaboration with Procurement and Outsourcing teams, ensuring creation of out-of-scope logs and related Change Orders. • Support Clinical Team in revision/preparation of SOPs, WKIs and related document templates, as well as maintain up-to date knowledge of ICH GCP and relevant regulations. Who we’re looking for • Bachelor’s, Master’s Degree or PhD in Life Sciences. • Substantial experience leading clinical studies and clinical trial monitoring in a pharmaceutical, biotech company or a CRO. • Good knowledge of EDC systems (e.g. InForm, RAVE, TrialMaster), electronic Trial Master File (e.g. Veeva, Medidata, IQVIA). • Previous experience in management of Real-World Evidence Studies and epidemiological studies is an advantage • Strong interpersonal skills, ability to collaborate within teams and sound project management skills. • Good knowledge of MS Office Suite, capacity to learn the use of other IT tools. • Fluent in written and verbal English. Knowledge of other languages an advantage. 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. #LIJobs

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