Clinical Operations and Project Manager/Clinical Trial & Data Manager

PMP® and Lean Six Sigma Black Belt certified Clinical Operations and Project Manager with over 8 years of experience in global clinical trial operations, quality oversight and data management. Certified in Clinical Trial Management with proven success in leading end-to-end global clinical trial projects for CROs, sponsors and sites across the US, Canada, and Switzerland, ensuring on-time, on-budget, and high-quality delivery in compliance with ICH-GCP and global regulatory standards (FDA, EMA, Swissmedic). Skilled in resource planning, process optimization, and cross-functional team leadership, driving operational excellence and continuous improvement. Based in Zürich, holding a Swiss B Permit (eligible for full-time employment), fluent in English, conversational in **German (**pursuing B1) and elementary in French (pursuing A1).

CORE COMPETENCIES

➢ Clinical Operations & Data Management: Site operations support, site monitoring oversight, TMF (Trial Master File) oversight & inspection readiness, CTMS/CDMS/eTMF (OnCore, Allegro, Clinical Conductor, OpenClinica, Medidata Rave, Veeva Vault. REDCap), EDC, eCRF design, edit checks programming, database validation, CSV, CDISC standards (CDASH, SEND, SDTM, ADaM), eSource, eCOA, MedDRA, CTA, protocol & ICF development, CMC and medical devices.

➢ Clinical Trial Management & Delivery: Phase I–IV study delivery, clinical trial planning, study start-up, conduct & close-out, cross-functional study leadership, country/site operational coordination, development of patient calendars, timelines & milestones, budgets, risk and issue management.

➢ Project & Program Management: PMP® certified with expertise in end-to-end project and program management using Predictive (Waterfall), Agile, and Hybrid methodologies. Skilled in planning & forecasting, managing schedule, budget, risk, resources, quality, vendor & stakeholder engagement and coordination.

➢ Regulatory, Quality & Compliance: Lean Six Sigma Black Belt certified with experience and strong knowledge of ICH-GCP, HIPAA, GDPR, GLP, GVP & GMP guidelines, FDA/EMA/Swissmedic frameworks, ethics/IRB support, safety management (pharmacovigilance), audit & inspection readiness, CAPA, QC/QA reviews, UAT, and continuous process improvement.

➢ Team Leadership & Training: Led cross-functional teams of up to 15 members; developed and managed resources, training & mentoring, KPI & performance management, created SOPs & processes, cross-functional communication and query management, and served as a Subject Matter Expert.

➢ Customer & Stakeholder Engagement: Collaborated with 100+ global clients (CROs, research sites, investigators and sponsors), ensuring high satisfaction and timely project execution through effective communication and proactive coordination.

➢ Business Tools: MS Office (Excel, PowerPoint, MS Project, Visio, Outlook, Planner), Jira, SharePoint, Slack, Zendesk, Bizagi, Banana Accounting etc.