PROFESSIONAL EXPERIENCE
General Management experience
- Develop and maintain the Company budget.
- Oversee the company?s compliance with legal guidelines, policies and quality standards.
- Manage the company financial aspects with tax office, bookkeeper, national and international tax advisors.
- Overseeing contractor performance and if necessary, take disciplinary measures in a constructive manner.
- Hire contractors to ensure the company/clients are staffed with qualified personnel.
Clinical Monitoring Experience:
- Set Up Of Multinational Clinical Trials
- Monitor Oversight Visits
- Site Evaluations Visits
- Study Start up activities (including coordination with vendors)
- Site Initiation Visits
- Monitor Visits
- Assisting in Sponsor Site Audits and work in conjunction with the sponsor as required to fix issues/CAPA FUP
- Close Out Visits
- Study Start Up activities comprising of Clinical submissions in the Netherlands, Belgium and Germany for several protocols, Contract Negotiation and Management, Key Opinion Leader Management, Clinical Operations Management.
Project Management Experience:
- Project management/coordination; Reporting to the development operation manager for clinical development, helping to manage and track clinical programs to both budget and time line requirements
- Initiating and coordinating feasibility assessment, potential investigator identification and site selection.
- Strategically planning and coordinating sponsored clinical trials (forecasting, resourcing, timelines, baseline recruitment)
- Adapting study documents and clinical contracts to meet local requirements
- Defining study specific processes including study communication plans
- Ensuring all study staff understand study deliverables and timelines
- Tracking local trial implementation, data collection and study reporting
- Review and approval monitoring reports and Site Initiation Packages (SIPs)
- Responsible with Medical staff for vendor selection and performance evaluation for local studies (services other than FSP)
- Providing regular updates on study progress to the Development Operation Manager and study sponsors as required, identifying barriers to site activation and patient enrollment and identifying potential solutions
- Ensuring quality of study execution
- Escalating study-related issues
- Providing Sponsor presence at investigator meetings / key visits
- Coordinating & actively participating at local investigators meetings
- Review of QA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues
- Providing hands on support in regards to regulatory submissions, contact with competent authorities, strategy and SOPs
- Translation regional strategic objectives to the local level
- Identifies and highlights risk areas (concerning operational readiness, communication and management)
- Ensures CRA receives necessary Therapeutic Area-related and study-related training
- Coordinates local study-related administrative tasks e.g. information to finance, status update to Business Unit, status updates in local meetings
- Working closely with vendor?s on site selection, recruitment and CRA reports
- Tracking local trial implementation, data collection and study reporting
- Review and approval monitoring reports and Site Initiation Packages (SIPs)
- Responsible with Medical staff for vendor selection and performance evaluation
- Single point of contact at a project level for Logistic Operation Center staff and Global Safety Management
- Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) for local studies (services other than FSP)
- Liaising with the Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow-up
Current client/role:
- ARC regulatory/CRA (since 08/2016)
- Beaufort CRO/Oversight Monitor (since 04/2024)
- Donawa Srl/CRA (since 03/2024)
INTRODUCTION
- I am a freelance consultant in the field of clinical research. I am able to effectively and efficiently plan, budget, set-up and maintain several clinical trials with either devices, pharmaceutical product (or a combination of both) in multiple European countries with emphasis on training and implementation of high quality of these research projects.
- For the set up of such projects I excel in communication and cooperation with internal departments of the client as well as external vendors, who co-participate in these projects. My objective is to give my overall attention to detail and verify accuracy in research trials and to continue my efforts to train and assist clients in the need for ?attention to detail? necessary to perform and excel in the execution of the clinical programs involved, in order to obtain higher productivity and a higher quality of the data. High standards and quality assurance in the clinical field are at the top of my list.
- As a manager I am facilitating and supporting the staff in the field, where I emphasize on keeping the timelines and supporting them in order to conduct the research projects in an orderly manner, where again the emphasis is on high quality of the research conducted.
- In order to achieve this I strongly emphasize to the use of pro-activity as well as combining the strengths of my co-workers through positive teamwork (which implies vision, leadership, values and respect) in order to inspire co-workers to continuously improve themselves.
- Being involved in clinical studies as an (oversight) monitor enables me to make good assessments and decision as well as set and keep strict timelines and informing my supervisors of the proceedings of the different projects.
ACHIEVEMENT OF GOALS
- I have been working within the pharmaceutical industry since 1998. In July 2009 I started my own company as a freelance consultant. I have participated since then in numerous clinical projects in several therapeutic areas. Spear points for excelling in these projects have been obtaining swift approvals for regulatory submissions to regulatory agencies and ethics committees, rapid contract negotiations with the vendors and clinical research sites involved, resulting in a quick and efficient start-up of the clinical protocols. I am particularly proud of the good relations and support that have yielded an excellent cooperation between myself and these clients, sites, key opinion leaders in the assigned therapeutic area in order to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
- My previous experience at clinical research organizations and pharmaceutical companies in an international setting has enabled me to work in a multicultural environment and develop a deep and thorough understanding of the pharmaceutical R&D-process as well as the legal framework these activities fall into. In the past I have been part and have lead and supervised highly educated team members from a wide variety of backgrounds. My enthusiasm, persuasiveness, tenacity and learning skills enabled me to master and excel at multiple projects.
MEDICAL FIELDS OF EXPERIENCE
- Since 1998 I have performed in multiple clinical programs which have enabled me to get a thorough understanding and experience of the following medical fields:
Internal Medicine:
- Crohn?s Disease
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Renal Micro-Albuminuria
- Osteoarthritis
- COPD
Hematology:
- Hemophilia A
- Multiple Myeloma
- Folicular Lymphoma
- Mantle Cell Lymphoma
- Acute Myeloid Leukemia
- Chronic Lymphoid Leukemia (B-CLL)
- Peripheral T-Cell Lymphoma (PTCL)
- Factor VII
- Von Willebrand?disease.
Infectious Disease:
- systemic fungal infections
- HBV
- HCV
- HIV/AIDS
Oncology:
- (Non) Small Cell Lung Cancer
- Prostate Cancer
- Ovarian Cancer
Cardiology:
- Vascular targeted therapies
- Acute Coronary Syndrome
Interventional Cardiology:
- PCI (Drug Eluting Stents)
- Implantable Cardioverter Defibrillators (ICDs)
- TAVI/TAVR
- Vascular targeted therapies
Ophtalmology:
- Retinitis Pigmentosa, Cataract (Intraoccular Lenses (IOLs)), Dry Eye.
Dermatology:
Urology/Genaecology:
- Over-Active Bladder Syndrome
Neurology:
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Multiple Sclerosis (MS)
CLINICAL FIELDS OF EXPERIENCE
Since 1998 I have performed in multiple clinical programs which have enabled me to get a thorough understanding and experience of the following Clinical fields;
- Operational project management of cardiovascular trials.
- Contributing to the medical/scientific input given for the development of trial-related documents and processes (including protocols and IB/IMPD).
- Responsible author for clinical protocols and amendments
- Collaborate with the Medical Directors and Key Opinion Leaders to ensure their feedback is integrated into protocol
- Performing submissions to and follow up for obtaining approval from internal review boards, Ethics Committees and Competent Authorities
- Contribute to the development of clinical sections of regulatory documents (IND/NDA submission documents)
- Training of clinical trial program personnel and sites as well as being responsible for the planning of all internal clinical meetings related to the clinical program.
- Having effective working relationships with key investigators and opinion leaders in assigned therapeutic area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
- Leading a multidisciplinary clinical trial team as their Clinical Operations Manager for several studies in a large Bio-pharmaceutical Company (ensuring that all trial deliverables are met according to timelines, budget, and resource requirements)
- Leading trial level interactions with Pharmacovigilance/Medical Safety and Drug Supply Management
- In collaboration with the Data Management, prepare and lead the clinical trial data through ongoing medical/scientific review, final analysis and interpretation of clinical evaluation committees. Responsible for preparation of clinical case and trial reports as well as responsible for communication/publication of these evaluation reports to the clinical personnel involved as well as regulatory Authorities and Ethic Committees)
- Management of trial resources (Forecasts, Budget Implementations, Preparation of Clinical Trial Contracts)
- Thorough knowledge of clinical trial laws in Germany, Belgium and the Netherlands
- Contribute to (early) program strategies
- Good inside knowledge of the Clinical Vendor and CRO market.
- Excellent knowledge of ICH/GCP and broad experience in monitoring and auditing of clinical trials
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards
- Management of CRO
- Management of Vendor-CRO (including Contract)
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
- Co-Responsible for the study protocol and report development
- Manage site selection process and CRO/site communication throughout the studies.
- Oversight of enrolment activities on a global/country/ site level, addressing patient enrolment risks, audit preparation and follow-up
- Design, review and approve trial related documentation
- Interfaces with clinical data management and statistics in developing case report forms, managing data clean-up, and analyzing study data
- Management of CRO, investigators, sites, IRB and ensure accurate tracking and reporting of study results and timelines
- Oversight of clinical monitoring activities
- Coordination of submissions to Competent Authorities
- Generate budgets for studies and budgetary reporting
- Develop clinical study reports
- Develop and submit manuscripts for publication in peer-reviewed journals and the subsequent revision and resubmission
- Develop abstracts and posters for presentations
- Support database maintenance
LEGAL FIELDS OF EXPERIENCE
- Since 2009 as a freelancer I have performed in multiple clinical programs legal tasks, below is a summary of the trials and skills used;
01/2017 - 01/2022:
Role: clinical Research associate
Customer: EXOM Group srl.
Tasks:
EXOM Group srl.: As a clinical Research associate for 1 Phase III study:
- Creation and processing of Clinical Trail Agreements in Netherlands and Belgium
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to local clinical regulations
10/2019 - 12/2021:
Role: Project Manager
Customer: Aspen Pharma
Tasks:
Aspen Pharma, Project Manager Western EU for a phase 3 HIT study
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues
11/2018 -
11/2019:
Role: clinical Research associate
Customer: PhysIOL
Tasks:
PhysIOL: As a clinical Research associate for 14 Phase IV studies in 8 countries:
- Review of the Clinical Trail Agreements template.
09/2014 - 06/2018:
Role: clinical Research associate
Customer: GAEA Clinical
Tasks:
GAEA Clinical: as a clinical Research associate for 1 Phase I/II study:
- Creation and processing of Clinical Trail Agreements in Netherlands and Belgium
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to local clinical regulations
02/2017 - 02/2018:
Role: clinical Research associate
Customer: Innopharma srl.
Tasks:
Innopharma srl.: As a clinical Research associate for 1 Phase III study:
- Creation and processing of Clinical Trail Agreements in Netherlands and Belgium
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to local clinical regulations
02/2011 - 10/2015:
Role: clinical Research associate
Customer: Fulcrum Pharma plc (now part of ICON plc)
Tasks:
Fulcrum Pharma plc (now part of ICON plc): as a clinical Research associate for 4 Phase III studies:
- Creation and processing of Clinical Trail Agreements in Netherlands and Belgium
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to local clinical regulations
01/2011 - 08/2012:
Role: clinical Research associate
Customer: PSI-CRO
Tasks:
PSI-CRO: as a clinical Research associate for 4 Phase III studies:
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to local clinical regulations
- Creation and processing of Clinical Trail Agreements
10/2009 - 04/2010:
Role: clinical operations manager
Customer: Amgen
Tasks:
Amgen: as a clinical operations manager for Oncology Phase II studies:
- Contracting & contract management with hospitals, investigators and study centers
- Main contact for legal issues with regards to 6 clinical trials
- Management of FSP-CRO with regards to 6 clinical trials
- Management of Vendor-CRO (including Contract) with regards to 6 clinical trials.
- Creation and processing of Clinical Trail Agreements