12/01/2025 updated
DS
100 % available
Lead Clinical Research Associate - Global Clinical Trial Management
Leiden, Netherlands
Only remote
Bachelor of Science (B.Sc.), MicrobiologyData AnalysisAsanaAtlassian ConfluenceBiotechnologyCardiologyClinical Data RepositoryClinical ResearchClinical Trial Management SystemsComplianceData ManagementProject PlanningDocument Management SystemsElectronicsPerformance ManagementGood Clinical Practices (GCP)
Clinical Trial Management
Global Phase I-IV clinical trial management with expertise in ICH-GCP compliance, regulatory oversight, and cross-functional team leadership across pharmaceutical and biotechnology environments
Regulatory Compliance
Comprehensive knowledge of ICH-GCP, FDA, EMA, and EU-CTR regulations with proven track record in ensuring adherence to international regulatory guidelines and local requirements
CRO and Vendor Management
Extensive experience in managing Contract Research Organizations, specialty vendors, and regional teams while ensuring adherence to scope, budget, and contracted deliverables
Clinical Data Systems
Proficiency in Medidata Rave, Oracle InForm, Veeva Vault CTMS/eTMF/EDC, and TransPerfect Trial Interactive systems for clinical trial data management
Project Management Tools
Advanced skills in MS Project, Smartsheet, Asana, and Trello for comprehensive project planning, tracking, and budget management
Data Analysis and Reporting
Expertise in JReview, SAS outputs, and Tableau for clinical data review, statistical analysis, and performance dashboard creation
Collaboration Platforms
Proficient in SharePoint, MS Teams, Zoom, and Confluence for cross-functional team communication and document management
Electronic Documentation
Experience with DocuSign, Adobe Sign, Medrio eConsent, TrialMax, and Medable for electronic trial documentation and patient consent management
Therapeutic Area Expertise
Specialized knowledge spanning oncology, CNS, pulmonology, metabolic disorders, ophthalmology, cardiovascular, and infectious diseases
Global Phase I-IV clinical trial management with expertise in ICH-GCP compliance, regulatory oversight, and cross-functional team leadership across pharmaceutical and biotechnology environments
Regulatory Compliance
Comprehensive knowledge of ICH-GCP, FDA, EMA, and EU-CTR regulations with proven track record in ensuring adherence to international regulatory guidelines and local requirements
CRO and Vendor Management
Extensive experience in managing Contract Research Organizations, specialty vendors, and regional teams while ensuring adherence to scope, budget, and contracted deliverables
Clinical Data Systems
Proficiency in Medidata Rave, Oracle InForm, Veeva Vault CTMS/eTMF/EDC, and TransPerfect Trial Interactive systems for clinical trial data management
Project Management Tools
Advanced skills in MS Project, Smartsheet, Asana, and Trello for comprehensive project planning, tracking, and budget management
Data Analysis and Reporting
Expertise in JReview, SAS outputs, and Tableau for clinical data review, statistical analysis, and performance dashboard creation
Collaboration Platforms
Proficient in SharePoint, MS Teams, Zoom, and Confluence for cross-functional team communication and document management
Electronic Documentation
Experience with DocuSign, Adobe Sign, Medrio eConsent, TrialMax, and Medable for electronic trial documentation and patient consent management
Therapeutic Area Expertise
Specialized knowledge spanning oncology, CNS, pulmonology, metabolic disorders, ophthalmology, cardiovascular, and infectious diseases
Experience
Professional experience5 - 10 years
Freelancer since2016
Languages
EnglishNative speaker
Project history
Lead and coordinate global Phase I-III clinical trials in oncology, neurology, and rare diseases, ensuring full compliance with ICH-GCP and international regulatory guidelines. Manage and mentor regional CRAs, CTAs, and field teams while providing oversight of CROs and specialty vendors.
Managed 10-15 Phase I-IV studies across oncology, cardiovascular, CNS, pulmonology, metabolic, and infectious disease indications. Oversaw CRO and vendor deliverables, negotiated site budgets, and delivered project productivity dashboards to leadership.
Authored CSRs, protocols, safety summaries, NDAs, IB updates, and regulatory documentation in oncology, neurology, and rare diseases. Partnered with clinical scientists and development leads to align trial data with regulatory and scientific requirements.