CTMS
- Siebel
- Veeva Vault
MartaPuricelli
Senior Clinical Research Professional
& Biomedical Engineer
Profile
Biomedical engineer and Clinical Research Associate with five years of experience monitoring and coordinating Phase I–IV international clinical trials in a CRO environment. Therapeutic exposure across neuroscience, hepatology, oncology, pulmonology, cardiovascular, infectious diseases and rare disorders. Consistent focus on ICH-GCP compliance, ALCOA+ data integrity and audit readiness. Primary CRA on three audits and two Swissmedic inspections — all closed with no critical findings. Engineering background and training in EU MDR 2017/745 and BCI / neurotechnology provide a working bridge between clinical operations and medical device development.
- 5
- years in clinical research
- 7
- therapeutic areas
- 18
- clinical studies as primary CRA
Core Competencies
- Site management and monitoring across visit types (PSV, SIV, IMV, COV) and approaches (risk-based monitoring, targeted SDV).
- Audit and inspection readiness; root cause analysis (5-Whys, Fishbone) and CAPA design and follow-up.
- Stakeholder coordination across sponsors, sites and external vendors; site-level milestone tracking.
- Regulatory and quality framework: ICH-GCP, ALCOA+, EU MDR 2017/745.
PHASES
- Phase I
- Phase II
- Phase III
- Phase IV
STUDY DESIGN
- Randomised
- Open-label
- Double-blind
- Placebo-controlled
- Long-Term Extension (LTE)
MONITORING ROLE
- Blinded CRA
- Unblinded CRA
Experience
-
Senior Clinical Research Associate
PPD · Thermo Fisher Scientific · Remote, Switzerland
- Primary point of contact for high-priority sites; oversee assigned clinical projects from study start-up through database lock and close-out.
- Mentor junior CRAs, review their monitoring deliverables and support team-level compliance with ICH-GCP and ALCOA+.
- Primary CRA in two Swissmedic inspections, two sponsor audits and one internal audit — all closed with no critical findings, with CAPA follow-up.
- Applied structured project management to the Long-Term Extension phase of one study, with measurable gains in process efficiency.
- Contributed to recruitment strategies on a portfolio of studies where over half exceeded enrolment targets, with timeline gains of three to five months.
-
Clinical Research Associate II
PPD · Thermo Fisher Scientific · Remote, Switzerland
- Identified and mitigated patient safety risks through proactive assessments; on four occasions prevented incorrect IP intake (damaged IP, incorrect dosing).
- Onboarded six study-naïve sites through structured training and KPI tracking; protocol deviations and aging findings reduced by ~60% on average.
- Mentored two junior CRAs across PSV, SIV, IMV and COV visit types until they could conduct visits independently.
- Performed root cause analysis (5-Whys, Fishbone) and supported CAPA design for audit and inspection readiness.
-
Clinical Research Associate I
PPD · Thermo Fisher Scientific · Remote, Switzerland
- End-to-end site management: selection, activation, monitoring, data review (SDV/SDR), IP accountability and ISF management.
- Resolved site activation barriers and aligned site capabilities with sponsor expectations.
- Adapted monitoring strategies to maintain on-time delivery during periods of resource constraint.
-
Remote Site Monitor
PPD · Thermo Fisher Scientific · Remote, Switzerland
- Remote oversight of study sites through site management calls and centralised monitoring activities.
- Site engagement and recruitment support; site payments and management of contract and budget amendments.
-
HSE Postgraduate
Novartis Pharma Stein AG · Stein, Switzerland
- Compliance assessments in a pharmaceutical production environment; mask fit-testing and noise assessments to support occupational safety.
- Drafted SOPs and delivered safety training to production staff.
-
Scientific Assistant
ETH Zurich · Schwerzenbach, Switzerland
- Developed an in vitro 3D muscle model through co-cultivation of multiple cell types; viral culture for targeted genetic modifications.
- Gel polymerisation to create scaffolds, contributing to a reproducible 3D muscle model.
Therapeutic Areas
Studies monitored or coordinated across the following domains.
- 01 Neurology
- Narcolepsy type I and II
- Multifocal Motor Neuropathy
- 02 Oncology
- Estrogen receptor-positive, HER2-negative early Breast cancer
- Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer
- 03 Pulmonology
- Pulmonary Arterial Hypertension (PAH)
- Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)
- 04 Cardiology
- Hypertrophic Cardiomyopathy
- 05 Hepatology
- Primary Biliary Cholangitis
- HFE-related Hereditary Hemochromatosis
- 06 Infectious Diseases
- HIV-1
- 07 Hematology
- Lymphoma (DLBCL)
- Waldenstrom macroglobulinemia
Clinical Systems
Hands-on platforms across CTMS, IxRS, eCRF, eTMF, central lab and specialised vendors.
IxRS
- Almac
- Endpoint
- Yprime
- Suvoda
- Signant Health
eCRF
- Medidata
- Alea
- Veeva Vault
eTMF
- Veeva Vault
- PhlexEview
CENTRAL LAB
- Labcorp
- Preclarus
SPECIALISED VENDORS
- Clario
- Signant Health
- Medable
- Empatica
- BTR
- Ambra
- Calyx
- Resonance Health
- Vitalograph
- LifeSphere
- Investigator Space
Education
2018 – 2021
M.Sc. Biomedical Engineering
Politecnico di Milano
2015 – 2018
B.Sc. Biomedical Engineering
Politecnico di Milano
Certifications & Continuing Training
- 2026 Certified Associate in Project Management (CAPM® — PMI) · In progress
- 2026 ICH E3 (R3) Guidelines
- 2024 Making Difficult Conversations Meaningful
- 2021 ensa Mental Health First Aid (Adults)
- 2020 BCI & Neurotechnology Spring School
- 2020 EU MDR 2017/745 — Easy Medical Device Mini-Course
- 2019 DISFIDA · TECNOARTERAPIA Award — digital rehabilitation for paediatric intensive care
Get in Touch
Available for full-time positions, B2B engagements, freelance projects, or contractor work — open to opportunities across Europe and North America.
Roles
- Clinical Operations Manager
- Clinical Trial / Project Manager
- Patient Engagement Manager