Medical Monitor
Il y a 7 mois
**Company Description**
PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
PSI **Medical Monitors **provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Office/hybrid in Leuven or home-based in Belgium
**Responsibilities**:
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the study from sites and the study team
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.
**Qualifications**
- Medical Doctor degree
- Oncology board certification is a must
- Prior and wide experience as a practicing Oncologist (minimum of 10 years)
- Full working proficiency in English
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
**Additional Information**
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
-
Medical Monitor
Il y a 7 mois
Leuven, Belgique PSI CRO Temps pleinCompany Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: PSI **Medical Monitors **provide medical...
-
Senior Cra Ii/ Lead Monitor
il y a 5 heures
Leuven, Belgique PSI CRO Temps pleinCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Senior Medical Advisor Io
Il y a 3 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Regulatory Affairs Expert
Il y a 3 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Marketing Manager Austria
Il y a 3 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
QA/ra Officer
Il y a 6 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Regulatory Affairs Specialist
Il y a 3 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Clinical Research Associate Be
Il y a 6 mois
Leuven, Belgique Panda International Temps plein**Clinical Research Associate BE**: **Location** - Leuven, Belgium **Contact name** - Sophie Krakers **Job ref** - 20725 **Published** - 7 months ago **Looking for a CRA in Belgium** For our partner, an organically growing CRO, we are looking for a Clinical Research Associate. This CRO provides phase I-IV clinical development services to the...
-
Molecular Scientist
il y a 22 heures
Leuven, Belgique Oxford Global Resources Temps plein**Molecular Scientist**: - Location: Leuven - Contact: Morgane Tordeur - Job type: Permanent - Contact phone: +32 (0)15 858 039 - Industry: Clinical Research Do you have a PhD in molecular science? We are looking for you! **Job description** Our client in Leuven is a CRO. We provide clinical development services to the biotechnology, pharmaceutical and...
-
Training and Professional Education Coordinator
il y a 4 semaines
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Middle East and North Africa Is Marketing Manager
Il y a 7 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Quality Systems Specialist
Il y a 7 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Quality Systems Expert
il y a 5 heures
Leuven, Belgique Terumo Europe Temps plein_At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Internal Control Business Partner
Il y a 7 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Quality Assurance and Regulatory Affairs
il y a 5 heures
Leuven, Belgique Comate Temps pleinComate is looking for a motivated **Quality Assurance and Regulatory Affairs (QA/RA) engineer **to support its growth and expansion in the **Life Sciences** sector. The aim of our passionate team is to cooperate with our clients in order to develop a unique product that is more innovative and more advanced than anything that is currently available on the...
-
Quality Systems Specialist
il y a 5 heures
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Purchasing Assistant
Il y a 6 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Supply Chain Coordinator
il y a 3 jours
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Our clinical operations activities are growing rapidly, and along with it our Supply Chain is growing more complex. We are currently seeking a full-time, Supply Chain Specialist to join our Clinical Operations team. This position partners with cross functional teams to ensure seamless communication with vendors in support of on-time delivery to...
-
Clinical Trial Lead
il y a 5 heures
Leuven, Belgique PSI CRO Temps pleinCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,300 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Product Manager Restorative Composites
Il y a 2 mois
Leuven, Belgique GC Europe Temps plein**GC Corporation** was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production, and distribution of a very wide range of dental products. Since 1972 **GC Europe NV,** our European Headquarter is located at the Researchpark Haasrode in Leuven. GC Europe NV supports and leads our different sales...