Bianca Groenendijk, Phd Email and Phone Number
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Bianca Groenendijk, Phd is a Clinical Research Professional | Owner Precision Clinical Solutions at Precision Clinical Solutions. She possess expertise in immunohistochemistry, cell biology, cell culture, scientific writing, molecular biology and 35 more skills. She is proficient in English. Colleagues describe her as "Bianca and I worked together in the ophthalmology team at ProQR Therapeutics, where she was overseeing the execution of a FIH study in a specialty disease area. Bianca took on additional trial management responsibilities, including vendor management and site payments where her organisational skills ensured the deliverables, GCP standard and timelines were met. Bianca's keen interest in clinical research and scientific curiosity lead to a thorough approach and support her natural authority that is an asset in Clinical Trial Manager/ Project Manager roles. Bianca's capabilities, reliability and respect for colleagues make her a much-appreciated part of the team." and "Bianca successfully switched end of 2015 from an academic career to one in the pharmaceutical industry, realizing that this would better fit her career ambitions. Starting as Clinical Trial Assistant Bianca's strong analytical and organizational skills enabled her to rapidly grow in and even outgrow her role as CTA. She developed a thorough understanding and knowledge of the clinical development process by taking on additional tasks and responsibilities far beyond the usual CTA scope of tasks. Bianca is ready to take the next step, whether as a CRA, Regulatory Associate, Clinical Scientist or Project Manager. She'll be an asset to any team who is looking for a sharp, knowledgeable, reliable, dedicated and motivated team member who independently makes herself familiar with content and processes."
Precision Clinical Solutions
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Clinical Research Professional | Owner Precision Clinical SolutionsPrecision Clinical SolutionsOegstgeest, Zh, Nl
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Clinical Trial ManagerLeyden Labs Feb 2023 - PresentLeiden, South Holland, Netherlands -
Clinical Trial Coordinator/ Ad Interim Clinical Trial ManagerProqr Therapeutics Nv Nov 2019 - Nov 2022LeidenActing 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 -
Clinical Trial CoordinatorEuropean Society For Blood And Marrow Transplantation Nov 2018 - Oct 2019Leiden, The NetherlandsProject 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) -
Associate Clinical Study ManagerAstellas Pharma Europe Dec 2017 - Sep 2018LeidenWorking 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
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Clinical Study AssociateAstellas Pharma Europe Dec 2015 - Nov 2017Leiden, The NetherlandsWorking 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
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Clinical Research Professional On Assignment For Astellas Pharma EuropeChiltern Dec 2015 - Sep 2018Leiden, The Netherlands -
PostdocErasmus Mc Mar 2008 - Feb 2013Department Of Experimental CardiologyTranslational (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 -
PostdocAcademic Medical Center (Amc) Jan 2006 - Feb 2008Department Of Medical BiochemistryResearch 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 -
Phd StudentLumc Feb 2001 - Mar 2006Department Of Anatomy & EmbryologyTitle 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 -
Clinical Research InternshipLeiden University Medical Center Oct 1999 - Jan 2001Department Of Gastroenterology And Hepathology -
Sales AssistantDe Bijenkorf Sep 1999 - Jan 2001Rotterdam Area, Netherlands -
Research Internship AbroadThe University Of Edinburgh Feb 1999 - Aug 1999Department Of Pathology, University Medical School, Edinburgh, Scotland -
Research InternshipLeiden University Medical Center Oct 1998 - Feb 1999Department Of Infectious Diseases -
Administrative AssistantSgs Nederland B.V. Jun 1996 - Aug 1996Spijkenisse Area, Netherlands
Bianca Groenendijk, Phd Skills
Bianca Groenendijk, Phd Education Details
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Biomedical Sciences -
Csg Blaise Pascal, Penta College
Frequently Asked Questions about Bianca Groenendijk, Phd
What company does Bianca Groenendijk, Phd work for?
Bianca Groenendijk, Phd works for Precision Clinical Solutions
What is Bianca Groenendijk, Phd's role at the current company?
Bianca Groenendijk, Phd's current role is Clinical Research Professional | Owner Precision Clinical Solutions.
What is Bianca Groenendijk, Phd's email address?
Bianca Groenendijk, Phd's email address is bg****@****oqr.com
What schools did Bianca Groenendijk, Phd attend?
Bianca Groenendijk, Phd attended Universiteit Leiden, Csg Blaise Pascal, Penta College.
What skills is Bianca Groenendijk, Phd known for?
Bianca Groenendijk, Phd has skills like Immunohistochemistry, Cell Biology, Cell Culture, Scientific Writing, Molecular Biology, Ich Gcp, Genetics, Dna, Lifesciences, Life Sciences, Clinical Trials, Sop.
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