Clinical Data Manager

vor 3 Wochen

Basel, Schweiz PMI Vollzeit

Critères de l'offre

**L'entreprise**: PMI

PMI

Description du poste
Clinical Data 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 Clinical Data Manager you will be in charge of leading end to end data management activities pertaining to clinical studies, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP.

More specifically, you'll
- Be responsible for the oversight of the CROs activities from study set-up to database lock:

- participate to the vendor selection
- review the protocol
- oversee the CRO activities and performance
- design and review the electronic Data Capture Tools (eCRF, ePRO)
- review the Data Validation Specification and Protocol Deviations Plan
- coordinate User Acceptance Testing (UAT) of the various systems
- review the Data Management Plan
- lead electronic data transfers between third parties
- oversee the data cleaning
- Organize internal data review meetings
- coordinate the medical coding and SAE reconciliation plan
- ensure the compliance of the study database with Clinical Data Interchange Standards Consortium standards (CDISC) and SDTM submission package requirements
- perform the quality control of the Data Management documentation within the Study Master File
- Act as the main point of contact with the CROs Data Manager and the Clinical Study Team, coordinate communications and lead issue resolution at study level.
- Participate to the review of the processes to ensure that processes are efficient, operational and aligned with the operating standards.
- Develop internal processes and standards for data acquisition, data management and SDTM mapping

Who we're looking for
- Bachelor or Master's Degree in Life Science
- Sound understanding of clinical trials methodology - terminology and substantial experience as Clinical Data Manager in Life Science companies
- Good experience supervising Clinical Research Organizations (CROs) and leading activities under ICH-GCP
- Good experience of Study Data Tabulation Model (SDTM) implementation. Familiar with Electronic Data Capture (EDC) system. SAS programming experience is an asset. Proficient in Excel, Word, PowerPoint
- Fluent in English, both written and spoken
- Excellent in work planning and time management.
- Able to work on multiple studies at the same time and in a changing environment with flexibility.
- Good communication skills with the ability to communicate with both technical and business areas.
- Confirmed leadership skills, ability to speak up and contribute to decision making.

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

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