Bianca Groenendijk, Phd Email & Phone Number

Oegstgeest, Zh, Nl

Leiden, South Holland, Netherlands

Leiden

Acting as Clinical Trial Manager for Phase I/IIb Ophthalmology Clinical Trials:• Set-up, execution and operational management of a clinical research study• Site feasibility, set-up and initiation, including site budget/contracts• Vendor setup and management, including vendor budget/contracts• Set-up/review of study documents, plans, manuals, and EDC system• Review Monitoring Visit Reports

Leiden, The Netherlands

Project Manager for Post Authorisation Safety Studies (PASS) and other prospective Non-Interventional Studies (NIS) in the field of Hematology/ Oncology on patients in the EBMT Registry. These studies are in collaboration with pharmaceutical companies on their Advanced Therapy Medicinal Products (ATMP) relating to Stem Cell Transplantation and/or Cellular Therapy, mostly CAR T-Cells, some pursuant to obligations imposed by the EMA.• Involved in eLearning Vendor selection; evaluate proposals and bid defences• Involved in the development of collaborations between EBMT and several pharmaceutical companies: meetings (TCs, F2F), reviewing research agreements, reviewing study protocols• Preparation for study management to perform the studies according to SOPs, protocol and applicable legislation and regulations (GVP, ENCePP Code of Conduct, GDPR)

Leiden

Working as a member of a Clinical Study Team responsible for a Global Phase III Clinical Trial in Paediatric Urology where every patient counts• Set-up, execution and operational management of a clinical research study• Manage internal and external cross-functional delivery teams and vendors• Assure global compliance with ICH-GCP, SOPs and Protocol• Management of site and vendor budgets/contracts• Clinical Data Review, ICF Review• UAT of eDiary system• Organising and presenting during well-received Investigator/CRA Meetings• Performing Site Visits

Leiden, The Netherlands

Working as a member of Clinical Study Teams responsible for Global Phase I and III Paediatric Clinical Trials Extra activities (delegated from Clinical Study Managers):• Clinical data/eCRF review• Review Monitoring Visit Reports• Performing co-Site Visit• Participate in Clinical/Medical Review Meeting• Organized well-received Investigator and CRA meetings• Participated in and assisted during Investigator and CRA meetings by interacting with Vendors, CRAs and Investigators, being a runner for questions, act as a moderator, presenting during break-out sessions and other miscellaneous tasks• Reviewed study documents and manuals, including synopsis/protocol/protocol amendments and patient leaflets, and developed and reviewed the TMF plan• Assisting in the development and distribution of Study Newsletters Extra activity on scientific/medical content (requested by Medical Lead)• Assisting in the development of a position paper to the FDA Main activities:• Set-up and maintain - ensure completeness and quality of - the Trial Master File (TMF)• Process investigator payments• Timely and accurate input of study-related information into the CTMS• Provide logistical support for the clinical program and associated clinical trials• Preparing and maintaining study-related spreadsheets/trackers• Participate in (Cross-Functional) Study Team meetings, review meeting materials, and prepare and distribute meeting minutes

Leiden, The Netherlands

Department Of Experimental Cardiology

Translational (to the clinic) studyResearch topic: Cell-based therapy of myocardial infarction.• Coordination, development, planning, execution, analysis, and reporting of the cardiovascular research project, resulting in a scientific publication• Maintaining contact/collaboration with other departments and pharmaceutical/biotech companies• Analyzing and reviewing clinical research, part of which resulted in a publication• Developing and performing in vitro and in vivo experiments (using SOPs)• Supervision of technicians, PhD-student and Research Master Medical student• Teaching in courses for PhD-students

Department Of Medical Biochemistry

Research to activin A and TGF-beta in relation to vascular smooth muscle cell-rich lesion formation.• Performing (micro-array) data analysis and developing, planning, executing,. analyzing and reporting of validating functional studies, resulting in a first author publication• Supervision of a practical training course

Department Of Anatomy & Embryology

Title PhD thesis:‘Influence of blood flow on shear stress responsive genes in the development of cardiac malformations. The involvement of the endothelin-1 pathway’.• Coordination, development, planning and execution of the biological research part of the multidisciplinary project. Resulting in publications and my thesis.• Collaborations with the Dept. of Aero- and Hydrodynamics, TU-Delft, Delft, and the Dept. of Obstetrics and Gynaecology, Erasmus MC, Rotterdam• Supervision of students and of practical training courses

Department Of Gastroenterology And Hepathology

Rotterdam Area, Netherlands

Department Of Pathology, University Medical School, Edinburgh, Scotland

Department Of Infectious Diseases

Spijkenisse Area, Netherlands

Msc, Biomedical Sciences

Education record