About me
About Me
Upon completing my Master in Biomedical Science in 2006 I decided to specialize in Clinical Research. I have a large experience in monitoring and managing (inter)national clinical trials (Phase II-IV, ISS & consortium study and registries). I have experience in preparation of global submission packages for several EU countries, executing site and vendor contracts, hiring and training of CRAs, writing and developing of study-related documents (e.g. ICFs) and management plans. Furthermore I have been involved in SOP development and revisions.
In addition to my clinical work I have gained experience in process optimization of lab sample management & logistics with a leading role regarding the implementation of a new software system.
I am a person who is enthusiastic and committed and can adjust in many different working environments quickly. I deliver high quality work within agreed timelines, with an eye for details but always keeping in mind the big picture. I learn and familiarize myself with new processes and documents efficiently.
Since 2018 I am NVFG member and part of the organizing committee of the NVFG ClinOpsday 2019 ‘Research Professional – van alle markten thuis’.
Experience
2018 - Present
JS|Clinical - owner
Freelance Clinical Research Professional
2010 - 2018
Danone Nutricia Research - Sr. Clinical Study Manager
International project manager for clinical trials within Adult Medical Nutrition department being overall responsible for the operational aspects of several (inter)national Clinical Studies according to GCP, including site feasibility and preparation of study documents, EC submission, budget control, CRO-, CRA- and site management, preparation and guidance for external site audit, monitor report review, co-monitoring, study closure. Expertise areas: Oncology, MCI & Alzheimer, ICU, WP EU Consortium Study, Investigator Initiated Studies and Danone Sponsored Studies within Europe & Asia.
2009 - 2010
Genzyme Europe BV - Inhouse CRA
International project manager for clinical phase 3 trial. Responsibilities include: CRO-, CRA- and site
management, preparation and guidance for external site audit, monitor report review, co-monitoring within an
ongoing study for cell therapy.
2007 - 2009
Sanofi-Aventis - CRA Medical Affairs & Clinical Operations (MACO)
Developing of different post-marketing studies (registries), conducting phase IIIb/IV clinical trials and managing two international studies. My responsibilities include protocol- and CRF development, budget control, train site study staff and area managers, performing site selection-, initiation-, monitoring- and close out visits.
Other Experience
Besides experience with the described fields of medicine/medical foods & the usual responsibilities of an (inter)national Study Manager the following experiences are gained:
- Implementation of Software Solutions
- Labsample Management & Logstics
- Risk Based Approach
- SOP development
- SPOC Contract Management
Main Education
2017
GCP training - E6 (R2) update
2007
GCP training
2006
Msc Biomedical Science
Main Indication Areas
* Including diabetes type 2, diabetes type 1 (children), hypertension, reumatology, osteoporosis, cosmetic surgery, cell therapy
Secondary activities
- Part of organizing committee NVFG ClinOpsDay 2019 ‘Research Professional – van alle markten thuis’
- 2018 NVFG Member
Personal Interests
Further Information
Upon request I can send you further detailed information such as my CV, any references and my current or future availability.
- www.jsclinical.nl
- jolanda.schavemaker@jsclinical.nl
- +31 (6) 11093209