Clinical Project Management
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In the past 20 years, I held several Clinical Research positions in the medical device and pharma industries (including CRO). In the role as a Clinical Project Manager my main areas of expertise are leading clinical study teams in order to ensure successful execution (from planning, execution until completion) of clinical studies and this within agreed timelines and budget. I was also responsible for vendor oversight and the creation of different study related essential documents (Clinical investigation Plan (CIP), ICF, IB, CRFs, TMF-eTMF, set-up of EDC, etc…), study plans and budget management.
As a person, I have been described as being patient, persistent, stress-resistant, organized, orderly, punctual, communicative, team player and people driver. What also important is, is to be customer focused to create long term relationships.
Saluda Medical, Harrogate – UK / Terheijden - NL 2020 – 2022
European Clinical Study Manager – Neuromodulation
Orchestrated the setup and follow-up of the Post Marketing Clinical Follow-up study, focusing on ECAP controlled, closed-loop stimulation with the Evoke Spinal Cord Stimulator (SCS) System. Managed prospective data collection for the EvokeTM Spinal Cord Stimulation System in treatment of chronic pain in a 'real-world' setting. Provided support and training to the salesforce for ensuring high-quality study data.
Search, selection, recruitment and management of Clinical Research Associates (CRAs) and Clinical Project Managers to join the core team. Ensured completion of studies within pre-defined timelines and allocated budgets (inclusive management of contracts with sites and vendors, payment and study budget forecasting).
Clinical Manager – Diabetology, Endocrinology
Led the coordination and implementation of pre-clinical animal and clinical human trials for a novel implantable device for continuous monitoring of glucose and other biomarkers. Collaborated closely with various departments and the Chief Medical Officer (CMO) aligning with the company's strategy. Managed pre-clinical trials including conditioning and training of mini-pigs, surgical procedures, and daily health evaluations.
Oversaw human clinical trials including start-up, initiation, patient recruitment, and closure of sites. Managed project budgets, contract negotiations with sites, performed fair market value assessments.
Clinical Contingent / Clinical Research Specialist – outsourced to Medtronic - Bakken Research Center
Supported clinical activities for the Engager Align and SURTAVI studies under the supervision of the EU – CRS Study Lead. Collaborated with the Global Study Core Team on various FDA studies including the TAVR Low Risk Study.
Principal, Clinical Project Management EMEA/AP – Cardiac Rhythm Management (CRM) and Neuromodulation (NMD)
Supervised study core team activities and managed clinical research projects. Search, selection, recruitment and management of Clinical Research Associates (CRAs) and Clinical Project Managers to join the core team. Administered protocol development, investigator selection, study conduct, and clinical report writing.
Ensured resource and financial budget alignment for clinical studies and contract management. Organised quarterly safety/complaint review meetings and collaborated with various departments for strategic alignment.
Senior Clinical Project Manager, Chronic Pain & Emerging Therapies EMEAC – Neuromodulation
Coordinated, performed search and selection, recruitment and management of Clinical Research Associates (CRAs) and Clinical Project Managers to join the core team. Study team for EMEAC driven Clinical Projects in various therapeutic areas. Developed and implemented study protocols adhering to SOPs, GCP, and ISO 14155 standards.
Managed study site selection, patient recruitment, contract management with sites and vendors and study budget/payments and forecasting. Provided logistic and clinical technical support to various departments. Coordinated and evaluated safety events ensuring proper documentation and compliance.
Clinical Projects Manager, EMEAC – Neuromodulation, Cyberonics, Brussels
Clinical Research Associate II, EMEAC - Cardiac Surgery, St. Jude Medical, Brussels
Clinical Project Leader, Astra Zeneca, Brussels
Clinical Research Associate I + II, Parexel International, Amsterdam
Medical Representative, Parke Davis – Warner Lambert, Zaventem
Hospital Nurse (Urology and Emergency Unit), AZ – VUB Jette, Brussels
