Basel, Basel, Switzerland
Clinical research professional with Ph.D in Translational and Molecular Medicine and master in Clinical Data Management. Solid understanding of clinical research and working experience as data manager for international trials. Excellent scientific background in oncology and neurobiology, result and delivering-driven mentality, with proven capabilities to produce, analyze, present and publish scientific data, as well as teaching and mentoring junior scientists and colleagues. Strong team player with extensive experience in global environments, and ability to lead working group of internal or external business partners. Flexible, well organized, reliable, problem-solving attitude, always keen on learning, and enthusiastic to face new challenges.
Leading Data Management activities for assigned clinical trials (interventional, non-interventional, real-world evidence), in different therapeutic areas (oncology, neurological, and infectious diseases) at start-up, conduct and closeout. • Project Management: ensuring data quality and timely delivery of study data to support project milestones; coordinate DM activities internally or externally, make DM decisions, provide and implement DM solutions, act as expert in DM problem-solving aspects; review DM sections from protocols and amendments to recognize and resolve issues that may affect database design, data validation and/or analysis/reporting. • Functional Service Providers (FSPs) Oversight: leading Functional Service Providers (CRO) for the data management deliverables of assigned clinical trials; ensure DM deliverables: eCRF design, completion guidelines, Data Management Plan, Data Validation Plan, Data Quality Review Plan, etc... are of high quality and delivered on time. • External vendor management: oversee development of data transfer agreements with external data providers (e.g. from analytical labs, genomics, and proteomics data, biomarkers, IxRS) ensuring use of standards & fit-for-purpose data models • Team lead and SME for non-CRF data to support the company in all matters related to external data collection • Building and maintaining strong collaborative relationships and effective partnerships with project teams as well as other internal communities, working groups, initiatives, internal and external stakeholders. • Acting as consultant, coach, trainer on tools, procedures, and cross-functional activities to peers, Functional Service Providers, External Business Partners, and any other stakeholder when required.
• Conducted multiple clinical trials in accordance with protocol and ICH-GCP standards. • Managed data entry in eCRF for various clinical trials with different sponsors. • Organized documentation and supported clinical monitors during site visits. • Stored documents in Trial Master File for easy access and reference.
- Pre-clinical research to characterize the biological mechanisms of the Amyotrophic Lateral Sclerosis, in the context of the project “ALS molecular therapy exploiting integrated small RNAs analysis of patient-derived induced pluripotent stem cells”. - Planning, organizing, conducting experiments, and data analysis; scientific data presentation and writing articles for peer-reviewed publication and grant requests; preparation of posters for scientific congresses; mentoring junior scientists. - Teaching activity (6 hours) for biology students at “Molecular Biology of Eukaryotes” course, University of Milano Bicocca; tutoring activity (20 hours) for biology students with learning disabilities (DSA students).
- Pre-clinical research on the doctoral project “Proteomic Characterization of the role of FUS/TLS in human cells: from pre-mRNA splicing to DNA damage response” - Pre-clinical research on oncology projects, and developed novel strategies for the qualitative and quantitative analysis of complex protein and peptides mixtures by mass spectrometry. - Authored 1 peer-reviewed publication.
- Developing of novel mass-spectrometric based strategies to identify low abundant post-translational modifications of proteins in human cells. - Setting of experimental procedures and protocols that are now available for the laboratory. - Authored 1 peer-reviewed publication.