Mark De Roij

Experience

• 

  University of Twente

  Jan 2005 - Jan 2009

  Characterization of mouse embryonic stem cells and induced pluripotent cells by qPCR analysis Assistant lecturer during the courses: "DNA technology" and "Bouw en werking van cellen", as part of the bachelor programme biomedical engineering. Travel coordinator in the study tour committee. Responsible for the organization of a three weeks long study tour through Brazil, visiting over 20 companies and universities with a group of 28 students and 2 professors. Chief editor of the Parallaks, a magazine of the student association Paradoks, published 6 times a year

  • BSc Thesis

    Jan 2009 - Jan 2009

  • Studentassistent 'DNA technologie' en 'Bouw en werking van cellen'

    Jan 2007 - Jan 2009

  • Travel Coordinator

    Jan 2007 - Jan 2008

  • Chief Editor of the Parallaks

    Jan 2005 - Jan 2007
• 

  Saxion

  Apr 2010 - Oct 2010

  Developing technical program for primary education.

  Integrating technology and science in interactive courses for primary school students

• 

  Restaurant Ouwe Compagnie

  Jul 2010 - May 2014

  Hulpkok

  Preparing cold starters and assist at the main dishes

• 

  Medisch Spectrum Twente

  Jan 2011 - Jan 2011

  Internship

  Validation of the use of the LightCycler 480 as a stable and precise measurement method to diagnose and follow patient with chronic myeloid leukaemia.During my internship I developed a validation plan to approve the LC 480 as a robust diagnostic tool for chronic myeloid leukeamia. Using patient-derived material I implemented RT-qPCR technology in a clinical environment.Techniques used: cell culture, RNA isolation, cDNA synthesis and RT-qPCR.

• 

  University of Twente

  Dec 2012 - Dec 2013

  MSc thesis

  MicroRNA-directed reprogramming and trans-dierentiation of human foreskin fibroblasts and keratinocytes towards induced pluripotent stem cells and endothelial cells.During my master thesis I have been working on reprogramming somatic cells into induced pluripotent stem cells with microRNAs. Moreover, I equiped myself with the ability to work independently and perform scientific research.Techniques used: cell culture, flow cytometry, immunofluorescence, fluorescence microscopy, transfection, cryopreservation, western blot, RNA isolation, cDNA synthesis and RT-qPCR. Show less

• 

  PharmaCell

  Jun 2014 - Dec 2015

  Biotech Associate

  Operating at the state-of-the-art cGMP-Licenced facility for human cell & tissue culturing and production of (bio) pharmaceuticals for international clients.April 2015 - December 2015: Involved in technology transfer. Implementing new techniques and materials, (re-)train (new) people on new equipment and write documentation (SOP's, batch records) for production operators.June 2014 - March 2015: As a production operator responsible for aseptic execution of cell culture for the treatment process of patients as well as for writing SOP’s, NC’s, CAPA’s and batch review. Show less

• 

  Synthon

  Jan 2016 - Oct 2023

  • Provide clinical, pharmacokinetic and statistical advices and other types of relevant input in all project stages• Pro-actively generate new ideas for developments.• Focus mainly on scientific activities.• Out-of-the box mentality• Is regarded expert within Synthon• Coordinate Clinical Evaluations and Post Marketing Clinical Follow-up studies for medical devices• Represents clinical department in project teams.• Leads discussions on biopharmaceutical concepts.• Contact with authorities, customers, patients, physicians and Key Opinion Leaders independently.• Develop clinical development strategy and designs successful pharmacokinetic or pharmacodynamic studies fully independent• Responsible for determining type and amount of studies and determines space for budget negotiations• Decision making with respect to CRO selection• Accountable for the delivery of the program to agreed timelines, scope, quality and budget.• Develop and determine strategy of projects and products independently.• Generate ideas for future development and therefore can impact future project portfolio.• Functional and non-functional coach for up to two junior colleagues Show less As a Clinical Research Associate at Synthon I'm involved in the organisation and monitoring of our BA/BE studies all over the world. Main responsibilities:- communication with CRO's all over the world- contract negotiation- review of study protocol, ICF and CRF- IMP shipment- writing monitoring plan and report- monitoring (clinical and bio analyitcal monitoring)- maintaing Trial Master File- review bio analytical method validation reports- review clinical study reports- insurance Show less

  • Trial Manager / Projectleider C

    Jan 2022 - Oct 2023

  • Trial Manager / Projectleider B

    Jan 2019 - Dec 2021

  • Trial Manager / Projectleider A

    Feb 2018 - Dec 2018

  • Clinical Research Associate

    Jan 2016 - Feb 2018
• 

  Novartis

  Oct 2023 - now

  Clinical Project Manager

  The Clinical Project Manager is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development studies in compliance with Novartis processes and regulatory requirements. The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with the Country Manager, Country Head, Feasibility Manager, Study Start-up Manager and Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned studies in end to end product line Clinical Operations Program Head/Study Lead/ CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio. Show less