Lead Clinical Studies and Logistics
Il y a 5 mois
We are currently seeking a **Lead Clinical Studies and Logistics** to join our “Clinical Development and Regulatory Affairs” team.
As our Lead Clinical Studies and Logistics, you will be responsible for planning, executing, maintaining oversight and report on clinical trials, from planning, vendor selection (if applicable) and site feasibility, through study close out.
You will play an active role in accomplishing our goals and in our company’s success.
Your responsibilities will be:
- To lead and provide direction to the cross-functional Study Management Team (SMT) to ensure all trial outputs from protocol development to final clinical study reports are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines;
- To build strong relationships with internal and external stakeholders;
- To understand from a scientific, biological and clinical angle the needs of the scientific community and defines the product specifications in terms of expected clinical outcomes. This to support correct medical decisions, based on proven and novel breakthrough-technology diagnostic tests;
- To develop and coordinate the development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study reports, in accordance with internal SOPs and GCP requirements;
- To define and drive study timelines and milestones;
- To oversee study approval processes for the Health Authority, EC/IRB approvals for all study documents as required;
- To oversee forecasting of study supplies ;
- To review and approve feasibility;
- To address enrolment and retention issues, identifying and implementing actions to keep studies on track;
- To ensure proper study documentation is maintained;
- To build a strong international network of KOLs and patient advocacy groups: understand the needs, gains new ideas and is able to challenge the current way of working to test and try new things;
- To keep abreast of industry trends and identifies opportunities.
- PhD degree in molecular biology, biochemistry or related disciplines;
- Minimum 3 years of industrial experience in clinical research or molecular diagnostics;
- Experience with IVD development and knowledge of regulatory context (IVDR and FDA) and intellectual property is required;
- Experience with molecular detection technologies (PCR, LAMP, NGS) is a strong plus;
- Expertise in design of experiments and statistical data analysis;
- Fluent in English (written and spoken); Knowledge of Dutch is an asset;
- Scientific and technology background in diagnostics, deep understanding of Clinical Laboratory practices;
- Expert knowledge in Infectious Diseases, flexibility to dive sporadically in other therapeutic areas;
- Solid record of developing and maintaining successful relationships with opinion leaders and investigators in various areas;
- Ability to thrive and deliver in a fast-paced, dynamic and highly multi-tasking environment;
- Strong organizational skills, proactivity, scientific curiosity with keen interest in novel technologies for molecular diagnostics;
- Strong communicator and planner: proven experience with steering cross-functional and self-steering teams;
- Manage third party collaborations and scout for new technologies and partners;
- Demonstrated innovative, critical thinking and problem-solving skills;
- Ability to translate scientific and clinical input from diverse fields into product requirements;
- Ability to drive decision-making within a multi-disciplinary and entrepreneurial team:
- Excellent interpersonal skills, including the ability to influence others
- Significant degree of autonomy
- Entrepreneurial mindset
- Team player, enthusiastic, accurate in execution and reporting;
- You feel comfortable in a start-up environment and you can easily switch from one task to another;
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues;
- Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.
-
Clinical Supply Chain Manager
Il y a 5 mois
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 1,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Experienced Clinical Database Programmer
Il y a 2 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Our global business is growing rapidly, and we are currently seeking a full-time office-based Clinical Database Programmer to join our Data Management team in our Leuven office. This position will work in a team to develop databases in which clinical data are captured and processed for analysis and reporting. The role requires the ability to...
-
Clinical Project Coordinator
Il y a 5 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Medpace Reference Laboratories is a global, full-service central clinical trial laboratory specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio, USA and we are active in over 80 countries across the globe. Medpace has established laboratories in the USA, Europe, Singapore, and China. Our services...
-
Clinical Database Programmer
Il y a 2 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Our global business is growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Programmer to join our Data Management team in our Leuven office. The position will work in a team to develop databases in which clinical data are captured and processed for analysis and reporting. This position plays a critical role...
-
Clinical Research Associate Be
Il y a 5 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...
-
Warehouse Worker
Il y a 2 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based **Warehouse worker** to join our Laboratory team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can...
-
Associate Clinical Trial Manager
il y a 1 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Responsibilities: - Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager - Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy - Compile and maintain project-specific status reports within the clinical trial management system - Interact...
-
Team Lead for Chip Engineering Logistics
il y a 3 semaines
Leuven, Belgique IMEC Inc. Temps pleinManagement - Leuven | Just now- Guide your logistics team to superb customer service and streamlined project timelines.- What you will doAre you passionate about technology? Are you interested in supporting a world-class team of engineers? Would you like to help customers innovate and optimize their timelines? The world of chip manufacturing is an...
-
Medical Monitor
Il y a 5 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...
-
Medical Monitor
Il y a 5 mois
Leuven, Belgique PSI CRO Temps plein**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...
-
Lead Planner
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...
-
Clinical Enrolment Manager Belgium
il y a 2 semaines
Leuven, Belgique Innovative Trials Temps plein**Start Date**: Mid/End November **FTE**: 0.2 **Location**: Belgium **Job Purpose** The Clinical Enrolment Manager (CEM) will perform site optimisation services in order to boost patient recruitment for clients’ clinical trials. The site optimisation services include, but are not limited to: Site Optimisation Calls - the telephone-based coaching of...
-
Clinical Trial Assistant
Il y a 5 mois
Leuven, Belgique UZ Leuven Temps plein**Verleg grenzen als clinical trial assistant binnen de dienst neurologie**: Momenteel hebben we een vacature voor een Clinical Trial Assistant (verpleegkunde) voor de dienst neurologie. **Dit betreft een 60% - 80% tewerkstelling. Indien gewenst kan je dit aanvullen met een tewerkstelling van 20 - 40% als verpleegkundige binnen een neurologie eenheid. Je...
-
Emea Medical Affairs Director Therapeutic
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...
-
Senior Medical Sciences Specialist Oncology
Il y a 5 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...
-
Leuven, Belgique KU Leuven Temps pleinA PhD in bioinformatics, computational biology, or a related field.Extensive experience in bioinformatics analysis, including statistical and computational approaches.Programming skills in R, Python, Matlab, or similar languages.A strong interest in immunology and experience with large-scale data analysis.Experience with machine learning approaches is an...
-
Lead Scientist
il y a 2 jours
Leuven, Belgique KU Leuven Temps pleinYou have a Master or PhD degree in Biomedical Sciences; Pharmaceutical sciences; (Bioscience) Engineering or equivalent through experience;You have extensive experience in the biopharmaceutical or related industry, with a focus on Chemistry, Manufacturing, and Controls (CMC) for cell and gene therapy products;You have proven track record in managing...
-
Senior Medical Advisor Io
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...
-
Warehouse Lead
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...
-
Logistics Coordinator
il y a 6 jours
Leuven, Belgique VIB Temps plein**Who we are**: The VIB - KU Leuven Center for Microbiology is part of KU Leuven and VIB (Flanders Institute for Biotechnology). We have a long-standing and successful history of translating scientific breakthroughs into impactful societal innovations and new innovative biotech companies. Our team of over 100 enthused scientists from all over the world...
