• Development, review, submission, and implementation of clinical research projects in multiple therapeutic areas.• Preparation for GCP audits and inspections. • Process improvement activities (SOPs, operational documents).

-Planning and operational management of clinical research activities.-Staff supervision.-Process optimization.

-Management of the Phase I Clinical Trial Sub-Unit.-Preparation and presentation of activity reports and KPIs.-Communication and coordination with external stakeholders.

-Coordination and supervision of Phase I, II, III studies activities.-SOPs development and validation.-Management of QA activities.

Set-up, execution and closure of the supply and distribution of IMP’s in the frame of Merck Serono`s international clinical trials.

-Administrative support and counselling to people living with HIV.  -Development of educative and preventive material regarding HIV issues.  -Communication and interaction within the associative network and the community life.

• Clinical trials management: Coordination of Phase I & II studies activities with the different laboratories and the pharmacyaccording to GCPs requirements.• Regulatory: Preparation, submission and negotiation of protocols to local regulatory authorities.• Communication with internal and external partners, monitors, MDs and sponsors, reporting.• Community education and trainings: Recruitment of study participants, development of communication materials, vulgarization and… Show more • Clinical trials management: Coordination of Phase I & II studies activities with the different laboratories and the pharmacyaccording to GCPs requirements.• Regulatory: Preparation, submission and negotiation of protocols to local regulatory authorities.• Communication with internal and external partners, monitors, MDs and sponsors, reporting.• Community education and trainings: Recruitment of study participants, development of communication materials, vulgarization and presentation of scientific activities.• Quality: Development and implementation of a quality management program according to DAIDS (Division of AIDS, NIH) policies and GCPs requirements. Quality assurance activities and updating of internal SOP’s. Show less

Analytical Support to Bioprocess Development under GMP conditions : SDS-PAGE, Western Blotting, IEF, ELISA, Biacore (SPR), HPLC reverse phase and ion exchange.

Production of Recombinant Proteins from Mammalian Cells:-Basic molecular biology : Transient transfections (CaPi, PEI).-Cell Culture : Eucaryotic cell culture (with or w/o agitation, bioreactor 1.5 and 4.5 L, TubeSpin highthroughput technology). -Analytic : ELISA, SDS-PAGE, Western Blotting.

Basic molecular biology: PCR (standard, mutagenesis), isolation and cloning of DNA fragments. Genomic DNA extraction. Plasmids transfections and transformations (heat-shock, electroporation, lipofection). Biochemistry : Cellular lysis and fractionation, immunoprecipitation, SDS- PAGE, Western Blotting, affinity purification. Microscopy : Immunohistochemistry and confocal microscopy. Cell Culture : Eucaryotic cell/bacteria culture, generation of stable clones, T-Cell stimulation.