Experience in clinical operations, research management, personnel supervision, direct report, clinical monitoring, medical writing, angioplasty, arthroplasty, bioanalytical sciences, preclinical, biomarkers, immunology, cell & molecular biology, medical devices, biotech, pharma, CROs • Study-related activities in a matrix environment for external and internal clients within timelines and budget • Authoring of CSR, CER reports, study protocols, monitoring plan, contracts, budgets, SOPs • Proven communication skills: HCP interaction, presentations, conferences, marketing material, posters, contract negotiation and scientific publications.
SKILLS & EXPERTISE
- Communication • Soft Skills • Detail-oriented • Autonomy • Tight Timelines • Team-oriented
- Monitoring • Protocols • eCRF/ Source Docs • eTMF • Contract Management
- Cardiovascular • Orthopedics • Biopharmaceuticals • Oncology • Biomarkers • MedDev
- Compliance: GCP (ICH E6 R2) Clinical Study Management • CITI Certification 2018 • Medical Device ISO 14155:2011 • GDP • Elec. Doc. 21 CFR Part 11 • GLP (21 CRF Part 58) • cGMP
- Computers: Microsoft Office Suite • Oracle & IBM EDC • LIMS (Watson) • Ariba • SAP
- Languages: French & English (fluent), Spanish (spoken)
As a research scientific/ project manager: development and GLP validation over 100 bioanalytical assays for large molecules such as Biomarkers, siRNA, antisense and IgG Therapeutics. Regulatory-compliant work in GLP, GCP and GMP settings and project management.
Basic and applied research in molecular and cell biology. R&D in small biotech. Interested in Bioanalysis / Diagnostics / Pharma / Biotech / Startups / Basic Research.
Nucleic Acids / Proteins / Immunoassays / Hybridization / Ligand-binding Assays / PCR / Oligonucleotide Therapeutics / Cloning & Expression / Virology & Cancer Research / Etc.