Koert Hermans

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.

Proficient in orchestrating multinational clinical trials, from pre-clinical animal studies to complex human trials, with a focus on innovative medical devices and therapeutic solutions. Demonstrated expertise in leading teams, optimising project resources, and ensuring compliance with SOPs, and international - local standards. Adept in protocol development, investigator selection, study conduct, and clinical report composition. Recognised for driving successful product launches and contributing to ground-breaking medical technologies. Committed to achieving project objectives within predefined timelines and budgets, whilst upholding the highest standards of data quality and ethical practices.

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).

• Achieved enrolment objectives as per the study plan across multiple sites in the UK, Belgium, the Netherlands, and Germany.
• Supported CE-mark achieved in June 2019 through effective study management and coordination.

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.

• Navigated pre-clinical and clinical trials, ensuring comprehensive data collection and documentation.
• Contributed significantly to the development of innovative needle-free glucose sensor technology.

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.

• Played a key role in the successful completion of a competent authority audit with Swiss Medic for the Low Risk study.
• Contributed to the successful FDA pre-audit for the SURTAVI study at Rigshospitalet Copenhagen.

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.

• Improved overall efficiency by coordinating the pre- and post-market clinical follow-up study for the Reliance 4 Front lead, leading to successful launch.
• Managed and coordinated study core teams for clinical research in chronic pain treatment and post-market clinical registries for Parkinson’s disease.

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.

• Achieved successful product launch in EMEAC by leading the pre-and post-market clinical study for EpiducerTM. 
• Acted as an advisor for investigators in setting up various investigator-driven studies and supported in obtaining approval for publications.

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

Diploma: Bachelor in hospital nursing (A1) - Higher Institute Paramedical Profession, Brussels

Clinical training related to management/regulatory guidelines/therapeutic domains in Clinical Trials

• SOP training, GCP and ISO 14155 refresher courses - (Maastricht, Medtronic (NL)
• Training – Time management & conflict handling (Boston SCX, Valencia - US
• Software package MS Projects, E-CRF, Oracle Medidata Rave (Boston SCX, Valencia – US, Brussels - BE 
• Med Dev Directive – ISO 14155 update course (St Jude Medical, Brussels – BE 
• Project management course (St Jude Medical, Brussels – BE 
• Multiple training courses on ICH/GCP and International regulations of interventional and non-interventional trials