Clinical R&d Leader
Il y a 6 mois
Location:
**Wavre**
**#22146**
**Clinical R&D Leader**
Brabant Wallon - Contracting
Our partner is looking for a **Clinical R&D Leader **to join its team. This international company is well-known for its pharmaceuticals and vaccines.
**Your responsibilities?**
- Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate
- Define the outline and content of the protocol,
- Assure that results meet the highest standards of quality and ethical conduct.
- Support to Independent Data Monitoring Committee (IDMC)
- Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer).
- Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program.
- Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
- Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
- Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
- Contribute to development of clinical section of regulatory files, including labeling.
**Your profile?**
- You hold a Master or a PhD secializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharma-co-epidemiology.
- You have knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP.
- You have at least 5 years experience within the pharmaceutical industry
- You have good knowledge of analytical techniques
- You are a proactive thinker and problem solver
- You speak French and English
**Our offer?**
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Do you have any questions? You can contact
**Aurélie Montes Suarez**:
or
** +32472/44.83.18
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