Clinical Research & Development Lead M/F > Joboolo BE :
Société : Aixial Group Lieu : Brussels Brussels Site source : Talent BE
Your tasks will be to (non-exhaustive list):
Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriateDefine the outline and content of the protocol,Analyse and interpret the results as a subject matter expert.Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical that results meet the highest standards of quality and ethical conduct.Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinicaldevelopment accountability for the medical/legal and human safety aspects of the clinical with Vigilance to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable.Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.Actively participate in preparing the clinical portion of the regulatory files and the registration processContribute to development of clinical section of regulatory files, including labeling.Professional experiences, qualifications and skills required :
PhD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or least 3 years of work experience in clinicalresearchKnowledge and understanding of vaccines, clinicalresearch, and biomedical research regulation, including ICH and GCPGood communication skillsLanguages :
Fluent in English (spoken and written) is mandatoryProficient in Dutch and/or French would be a plusWho Are we? We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity Join Us?Make a positive impact and be at the forefront of project:
You will be part of groundbreaking advancement in clinicalresearch that has positive impacts on millions of people’s lives Development:
People are our biggest asset.
We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork.
At AixialGroup, you will be coached and mentored throughout your journey to help you advance your professional and personal commitment to Diversity, Equality, and Inclusion:
We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their equality is at the core of the development strategy of AixialGroup continues to grow, and to recruit in the clinical trial professions.
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