Senior Manager RWE Operations – 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 Senior Manager RWE Operations, you will be responsible for the oversight of the RWE Study Managers in charge of execution of observational research studies in humans across multiple programs, as well as for coaching, mentoring and advising the RWE Study Managers to ensure that the studies are carried out in compliance with PMI's Quality Management System (QMS), the study protocols and adherence to ICH GCP/Good Epidemiological Practices (GEP), relevant regulations and best quality standards. You will ensure PMI success in this strategic area of substantiation of risk reduction of its Smoke Free Products (SFPs) through operational excellence and outstanding leadership.
You will be accountable to deliver operational activities for allocated RWE studies as per agreed timelines and budget and business strategy while relentlessly improving processes to support PMI to be more agile and innovative, as well as be responsible to allocate operational resources according to business strategy and to further develop the team to strengthen PMI scientific credibility externally. You will also report progress and raise issues to Global Head Clinical Operations, Global Head of RWE, program leaders, and senior management as appropriate.
In addition, you will be responsible for the implementation and execution of assigned RWE studies in humans including study planning, monitoring the progress and management and oversight of external and internal partners involved in the study execution.
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 step-up and implementation of clinical studies following ICH-GCP principles.
More specifically, you'll
In alignment with Life Sciences, Medical Sciences and company objectives, oversee all study related activities throughout the entire study duration, supervise all operational aspects of RWE studies in humans across multiple allocated programs (e.g. tobacco harm reduction, nicotine science, global medical plan) as per defined strategy and timelines including study set up, conduct and reporting of results worldwide.Lead the RWE study managers team ensuring the appropriate resources, systems and standards are in place for the conduct of RWE studies on SFPs. Ensure operational and technical oversight and guidance to the teams, provide vital coaching and mentoring to support personal development of the team members. Ensure implementation of continuous process, standards and methodologies improvements to ensure operational efficiency and increasing agility while ensuring compliance to international requirements. Line management, coaching and mentoring of RWE Study Managers.Guarantee that, for each assessment study performed under the supervision of the study operations an appropriate PMI study team with clear roles & responsibilities is assigned and the study is conducted in accordance with ICH GCP or GEP requirements (as applicable), PMI SOPs, WKIs and policies, any other relevant regulations, and within agreed timelines and budget. Ensure that any compliance issues are raised to Quality Assurance (QA), Function Heads and if necessary to Medical Sciences Management, and ensures that vital corrective and preventive actions are put in place.Be responsible for the establishment and implementation of standard operation procedures (SOP), Work Instructions (WKI) and quality systems within study execution team. Serve as a key resource to quality improvement programs in CR to ensure process efficiency and fostering improvements in study execution to support ongoing strategic imperatives of PMI. Maintain up-to date knowledge of relevant standards and regulations, in particular in the rapidly developing area of RWE.Participate to the selection process of Contract Research Organizations (CROs) including participation to bid defence meetings and assessment of proposals and provides recommendations to Global Head of Study Operations and Global Head of RWE. Ensure that the appropriate support to Procurement and/or Legal teams provided by RWE Study Managers in the process of selection and contracting of external parties.Participate to Governance Committees with external parties to ensure oversight, continuous improvement of the execution and support to ongoing and future projects undertaken as part of the partnership in order to achieve the goals and objectives of the studies. Serve as contact person for global study teams to raise any issues related to the execution of the RWE studies for SFPs.Serve as a technical leader for operational aspects, continuously striving for robust and quality results and operational efficiency. Lead and monitor all aspects of the execution of clinical and medical research studies in humans globally (including planning, setup, conduct and close-out) designed to assess smoke free products. For assigned studies coordinate the preparation of study related documents, (e.g. IB, Protocol Outlines, Protocols, Informed Consent Forms, Diaries Case Record Forms, Study Report etc.) and submissions to the Ethics Committees. For documents generated by external parties ensure 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 & investigators.Liaise with Life Science Projects Managers as well as other PMI functions, as necessary, act as a key pillar/back up to support the Global Head of Clinical Operations and Global Head of RWE during cross-functional Life Science program meetings.
Who we’re looking for
Master’s Degree or PhD in science, clinical operations, clinical study management, or equivalent experience and skills.Minimum 10 years’ experience in management of observational or clinical studies and clinical trial monitoring. Proficient in implementing study operations strategies including extensive knowledge of clinical assessment processes, all relevant clinical operations process as well as scientific methodologies. Minimum 3 years’ of experience in the management of observational studies with a prospective data collection component. Experience participating in the creation and nurturing of partnerships with data owners, e.g., academics, hospital networks, insurances.Previous experience in carrying out studies in the USA, EU and Japan.Ability to work under limited supervision from the supervisor who delegates team leader's responsibility for actions, decisions, and technical advice provided in clinical and medical research studies execution.Sound knowledge of ICH GCP, GEP and methodology of execution and monitoring of RWE studies.Good project management skills including use of tools such as MS Project.Good MS Office skills.Working knowledge electronic systems (e-TMF, EDC, others) used in the execution of various types of studies (RWE, clinical etc.).Excellent spoken and written English language skills.
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.
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