Clinical Project Manager
Since September 2022 Laura has joined the Qserve Group as Clinical Project Manager in the Qserve CRO team. She has almost ten years of experience working in the MedTech industry. She has a combined experience in medical device manufacturing processes and the conduct of clinical trials.
As Clinical Project Manager, Laura will be responsible to lead the planning, setup, and execution of clinical investigations for medical devices. She works in close collaboration with the sponsor to develop the required documentation and obtain ethics approval and competent authority approval as well as manage the study from beginning to end. Laura is based in the Netherlands.
Laura about working at Qserve
“Working along with experts in the field of MedTech Regulatory, Clinical and Quality Compliance is one the greatest things of Qserve Group. For me, working with clinical investigations in medical devices is being part of this complex and amazing puzzle that brings clinical solutions to many patients in the world.”
Laura’s background is in Chemical Engineering, and she worked as a Manufacturing Engineer for several medical devices companies where she performed all types of validation procedures. She has worked with cardiovascular devices, closed wound drainage, and negative pressure wound systems.
Later, she completed a master’s degree in biomedical engineering in business, and she transitioned to the Clinical Research Industry. Laura has conducted pharma studies and before joining Qserve, she was working in the management and conduct of orthopedic implant clinical investigations.
Laura holds a formal accreditation as a Clinical Research Professional by IAOCR (The International Accrediting Organization for Clinical Research) and she is also a certified Six Sigma Green Belt Professional by ASQ (American Society for Quality). Laura has a Bachelor’s degree in Chemical Engineering from the University of Costa Rica and a Master of Engineering in Biomedical with Business from The University of Melbourne.
The key expertise areas of Laura:
- Compliance with ICH GCP and ISO 14155 Guidelines
- Knowledge of several EDC platforms
- Development of project budgets and needs assessments such as monthly and annual budgets as well as annual needs assessments
- Setting up of clinical studies from obtaining the necessary approval from relevant review committees to conducting clinical monitoring site visits in order to provide general oversight to evaluate the performance and compliance levels of the sites and take appropriate action as required
- Review and management of study payments and reimbursements
- Review and provide input to improve clinical operations efficiency
- Languages: English and Spanish
Learn more about Qserve CRO