Regional Management
Regional Manager, Germany, Austria and Switzerland
ClinTec's Regional Manager for Germany, Austria and Switzerland has been with the company since 1999 and in this time has successfully Project-Managed numerous clinical trials across phases I – III in therapeutic areas such as Dermatology, Immunology, Rheumatology, Oncology and Cardiology. In addition to being responsible for all local regulatory submissions, he also manages a team of regional CRAs.
Before joining ClinTec, he worked for Baxter Deutschland as a Project Leader and Production Manager before moving into the field of Clinical Research. His experience in this field includes positions in Medical Writing, including an ad hoc position as a reviewer for two international Immunology Journals.
A graduate of L. Maximilians University with a Degree in Anthropology and Human Genetics, he completed a Master’s Thesis on Immunology at the Institute of Immunology, Munich before embarking on 4 years of research into HIV and completing a PhD in Immunology at the University of Munich.
Country Manager, Poland
Our Country Manager responsible for managing ClinTec’s Polish operations has over 15 years of experience in international clinical research and is a qualified Physician. She has experience overseeing clinical projects as Project Manager with the responsibility for organisational support and management of trials in Poland, Czech Republic, Slovakia and other CEE countries.
In her medical training, she specialised in Otolaryngology and also has experience in other therapeutic areas including Gynaecology, Cardiology, Diabetes, and Oncology in Phase II-IV studies. With considerable expertise in the area of Regulatory Affairs in Poland, she has worked as an EC and RA Submissions Specialist for 13 years, performing over 30 RA submissions and has been responsible for obtaining approvals for clinical studies from Phases II, III and IV.
Since joining ClinTec in 2004, she has been instrumental in expanding our Polish operations and now manages a large team of CRAs and CTAs in our Regional Office.
Associate Director, Regulatory Affairs & Operations
ClinTec's Associate Director of Regulatory Affairs & Operations in the Middle East has been with ClinTec since 2008 and has 15 years of experience in the clinical research field.
With considerable experience in both Regulatory and Ethics submissions in the region, she has been involved in writing SOPs for both the Institutional Ethics Committees and CROs. She has worked on multiple multinational trials across a variety of indications and therapeutic areas including Cardiology, Psychiatry, and Endocrinology / Metabolic Disorders.
After receiving a Masters in Pharmacy from MAHE University, majoring in Immunopharmacology and Cancer Chemotherapy, she began her clinical career as a CRA for a Global pharmaceutical company before moving on as a Clinical Research Advisor. She has worked within the Dubai Health Authority as Pharmacist and Medical Research Co-ordinator and was a member of the Medical Research Ethics Committee.
Additionally, she holds a certificate in GCP from the Thrombosis Research Institute, London, and is a member of the European Medical Writer’s Association.
Director, Asia Pacific
ClinTec's Director of Asia Pacific joined ClinTec in 2011 to head our development and growing operations in the Asia Pacific region. Bringing over 12 years of experience as a Senior Director in Pharmaceuticals and Biologics, she has led diverse teams in up to 42 countries across 12 functions in full cycle completion from Phases I-IV.
ClinTec's newest Director has hands-on experience in strategic planning, business unit development and project and product management. In her years of experience with global pharmaceutical companies, she has proven ability to successfully analyse a drug portfolio’s critical business requirements, identify deficiencies and potential opportunities and develop innovative and cost effective solutions for enhancing competitiveness. A graduate of Brown University, USA, she has a degree in Medicine, Psychology, and Economics as well as a Master’s in International Relations from Freie Universitaet, Germany.
Director of Operations, India & MEA
ClinTec’s Director of Operations across India & MEA is currently responsible for the oversight and development of these regions. Having joined ClinTec in 2002 as the Head of Medical and Scientific Services, she has taken on this senior role utilising her vast experience in the efficient and effective management of various clinical development verticals including Clinical Operations, Regulatory Affairs, Medical Writing, Quality Assurance and Training.
Prior to joining ClinTec she worked for various Pharmaceutical companies and CROs, as well as working as a freelance consultant for multiple clinical trials. During this period she was also selected for a 2 year secondment at the company’s Belgian Vaccine Headquarters, responsible for independent planning, implementation and supervision of clinical studies on developmental paediatric vaccines world-wide.
A graduate of Bangalore University, she has a Master of Pharmacy, majoring in Pharmaceuticals.
Country Manager, France
ClinTec's Country Manager for France has 16 years of experience in the pharmaceutical industry, incorporating 11 years in international clinical trials in positions such as Senior CRA and Project Manager, monitoring sites in France, Belgium, Italy, Spain and Portugal. In addition to experience in clinical trials from Phases II-IV, she has worked as a Consultant for Strategic Analysis, Inc. focusing on business intelligence projects for the pharmaceutical industry.
After taking up positions within international companies in both clinical and business development roles, she joined ClinTec and has been instrumental in expanding our operations throughout France.
With an M.A in International Relations from the Johns Hopkins University, Washington, D.C. and Bologna, Italy, she obtained a D.E.A from La Sorbonne in Paris France before carrying out doctoral studies in Economics.
Regional Director, Benelux
ClinTec’s Regional Director for Western and Northern Europe has over 18 years of experience in clinical research and has been with ClinTec since 2006. During this time, she has been responsible for building and developing the team in the Benelux region, in addition to taking the clinical monitoring lead in a global infertility study involving 12 countries over 3 continents – Australia, South America and Europe.
Trained as a medical microbiology analyst, she moved into clinical research as a Medical Representative and has since been involved in Phase II-IV trials across a broad range of therapeutic areas, including Anaesthesia, Pain Management, Cardiovascular disease, Endocrinology & Metabolism, Oncology and Rheumatology.
Regional Director, CEE & CIS
ClinTec's Regional Director for Central & Eastern Europe (CEE) and the Commonwealth of Independent States (CIS) spearheads our rapidly expanding team within this region. She is responsible for managing and developing ClinTec’s experienced team of Lead and Senior CRAs, Regulatory Associates and CTAs across Czech Republic, Slovakia, Russia, Ukraine and Balkan Region.
During 12 years in clinical research she was responsible for managing many complex global projects in Central and Eastern Europe from Phase I to Phase IV, across a number of therapeutic indications such as Urology, Gynecology, Endocrinology, Neurology and Oncology. She has a wealth of experience managing clinical trials in Czech Republic, Belgium, Romania, Bulgaria, Russia, Ukraine, Belarus and Uzbekistan.
With a perfect self-start and high achievement drive, she succesfully proved her ability to lead high profile initiatives within the business and manage multiple activities. She is a member of EFGCP and DIA and represents ClinTec in ACRO.
Country Manager, Egypt
ClinTec’s Country Manager in Egypt has been with ClinTec for 4 years and has 8 years of experience in the clinical research field. Having performed regulatory and ethics submissions throughout Northern Africa, including Egypt, Jordan, Kuwait and Lebanon, she has a wealth of experience and supports our operations throughout the region.
Prior to joining ClinTec, she worked for a Global CRO as a CRA in Cairo, where she was also involved in the coordination of other research colleagues for studies spanning multiple countries in the Middle East.
A graduate of Alexandria University, Egypt, she has a Bachelor's Degree in Pharmacy and is fully trained in ICH-GCP.
Regional Manager, Northern Europe and Baltic States
ClinTec's Regional Manager in Northern Europe and the Baltic States holds a strong background in Project Management; including managing a variety of full service projects and has experience in all aspects of drug and device development from pre-clinical to clinical trials, registration and marketing.
Having qualified as a Registered Nurse, she worked in internal medicine and cardiology for 8 years, before moving onto a career as a Research Nurse and Lecturer in heart diseases. She holds over 10 years of experience in clinical research with Investigator-initiated studies, Global Pharma companies, Medtech and Local Biotech companies.
Recent successes at ClinTec include the management of a suite of key global studies covering almost 20 countries across Europe, Africa, Latin America and Asia as well as local full service projects. Additionally, she has conducted successful feasibility studies and patient enrollment & retention projects.
Regional Manager, South Africa
ClinTec's Country Manager for South Africa joined ClinTec in January 2011 bringing with her 15 years of experience in the clinical industry.
Prior to joining ClinTec, she worked as a Monitor, Project Manager and Operations Manager for various international pharmaceutical companies and CROs. Her experience includes successful management of Phase I-IV trials in Cardiology, Ophthalmology, Gastroenterology, Infectious diseases, Pulmonology and Neurology. She has a sound knowledge of the local research industry and regulatory requirements, in addition to knowledge of clinical trials throughout Africa.
A graduate of Rand Afrikaans University, Johannesburg, she has a BSc in Biological Sciences and a post graduate diploma in Education. She has also received a Higher Certificate in Project Management.
Regional Manager, Spain and Portugal
Our Regional Manager for Spain and Portugal has over 16 years experience within the clinical research arena across a diverse range of therapeutic areas in phases I – IV. She has extensive experience of preparing and coordinating the applications and approvals to Regulatory Authorities at both a national and international level.
Her previous experience before joining ClinTec includes working for Global CROs in both Project Management and Regulatory Affairs positions. She was also a Clinical Research Manager for a CRO in Spain with overall responsibility for leading local and international clinical projects.
Having graduated in University Autonoma of Barcelona with a Bachelors Degree in Biochemistry, she worked at Yale University, USA, before moving into clinical research. She has also undertaken further training in Pharmacovigilance, Project Management, GCP and GLP.
Country Manager, Italy
ClinTec’s Country Manager in Italy has been with ClinTec since November 2010 and in responsible for managing all operations across the country. With over 10 years of experience in the pharmaceutical industry, he has worked in the full drug development process and has extensive experience across Phase II-IV.
Before joining ClinTec, he gained experience with international CROs and is well versed in EU and US regulations and has worked across a range of therapeutic areas including Gastroenterology, Cardiology, Infectious Diseases, Neurology and Oncology. He has extensive knowledge of Medical Device regulations and experience in project management, patient recruitment strategies and nutritional products trials.
He is a graduate of University La Sapienza with a master degree in Chemistry, attended several training as Clinical Project Manager and currently holds four professional memberships: SSFA (Italian Pharmaceutical Scientific Society); SSFA Medical Devices Working Group; Assomonitor (Italian Association of Monitors) and TOPRA (The Organisation for Professionals in Regulatory Affairs).