Clinical Trial Operations & Project Manager | Clinical Data Manager | Quality & Regulatory Expert

PMP® and Lean Six Sigma Black Belt–certified Clinical Operations & Project Manager with 8+ years of experience in global clinical trial operations (Phase I to IV), leading end-to-end project management across study start-up, conduct, and close-out, with strong expertise in quality oversight, regulatory affairs and clinical data management. Proven in leading cross-functional study teams, coordinating site-facing activities, ensuring ICH-GCP and regulatory compliance (FDA, EMA, and Swissmedic), consistently delivering clinical projects to time, cost, and quality expectations. Certified in Clinical Trial Management, with a strong background in study planning, risk and issue management, TMF oversight, audit readiness, and stakeholder leadership across CRO, sponsor, and sites. Based in Zürich, holding a Swiss B Permit, fluent in English, intermediate in German (B1), and elementary in French (A1 in progress).

CORE COMPETENCIES

Ø  Clinical Operations & Data Management: Site operations, protocol & ICF development, site monitoring, CTMS/CDMS/TMF management (OnCore, Allegro, Clinical Conductor, OpenClinica, Medidata Rave, Veeva Vault, REDCap), EDC, eCRF design, edit checks programming, data monitoring, database validation & lock, inspection readiness, CSV, CDISC standards (CDASH, SEND, SDTM, ADaM), source data review, eSource, eCOA, ePRO, MedDRA, CTA, CMC and medical devices.

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

Ø  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 scope, schedule, budget, risk, resources, quality, vendor (procurement), change management & stakeholder engagement.

Ø  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, IND/NDA/BLA submissions, De Novo and 510(K) regulatory submissions for medical devices, ethics/IRB support, safety management (pharmacovigilance), QMS, audit & inspection readiness, CAPA, QC/QA reviews, UAT, and continuous process improvement.

Ø  Team Leadership & Training: Led cross-functional teams of up to 15 members; developed and managed resources, training & mentoring, KPI & performance management, created SOPs & processes, documentation control, communications, query management.

Ø  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.

Ø  Business Tools: MS Office (Excel, PowerPoint, MS Project, Visio, Outlook, Planner), Jira, SharePoint, Slack, Zendesk, Salesforce, Bizagi, Banana Accounting, Generative AI tools, ML basics, Python basics, Salesforce, SQL basics, SAS etc.