« Clinical Study Manager » (M/F)
Promethera Biosciences is an international biotech company with headquarters in Belgium and US operations in North Carolina, developing innovative therapies for the treatment of liver diseases. Its proprietary cell-based technology platforms are based on mature hepatocytes and allogenic progenitor cells isolated from healthy adult human liver donors. Promethera Biosciences is today close to market with Heparesc, in clinical stage with HepaStem and in pre-clinical stage with H2Stem.
If you are sharing our vision of the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for inborn and acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 50 people, consider joining our fast growing company.
Promethera Biosciences is currently hiring a Clinical Study Manager to support the Clinical Department.
The selected candidate will:
- In collaboration with the Head of Clinical Development and the medical/clinical team, prepare and manage clinical trials with HepaStem (protocols, ICF, IDB, CRF’s, study files, etc.)
- Develop and write SOPs for the Clinical Research Department related to Clinical trials
- Prepare and start-up the clinical sites in due course, perform clinical monitoring when needed
- Train Promethera’s staff and clinical trial sites to clinical trial requirements
- Collaborate closely with the R&D and regulatory teams to fulfill the clinical trial requirements
- Engage and ensure coordination/project management with external resources (CRO’s)
- In collaboration with the Head of Clinical Development, organize and work-out advisory boards, investigators’meetings, seminars at congresses
- Educational background in disciplines of science, biomedical science or medicine/health care (MSc, PhD, MD)
- Prior experience in clinical monitoring (full process of a CT implementation: from protocol design until completion of trial and reporting of results)
- Excellent skills in literature reviews and eager to learn about new therapeutic area’s
- Excellent English writing skills
- Good English and French verbal communication skills
- Good Computer Skills (project management)
- Excellent organizational and communication skills (interaction with physicians and study site staff)
- Flexibility to operate in multitasks environment
- Experience in Advanced Therapy Medicinal Products and Orphan Drugs would be an advantage
- In our headquarters in Mont-Saint-Guibert near Brussels (Belgium)
You may apply for this position by sending your CV and application letter to firstname.lastname@example.org
Please note that, due to the high number of applications we receive, only retained candidates for interview will be contacted.
PROMETHERA Biosciences S.A./N.V.
Watson & Crick Hill
Rue Granbonpré, 11
Tél.: +32 (0)10 39 43 00
Fax: +32 (0)10 39 43 01