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Senior Study Start-Up Specialist

Have you been working in Study Start Up and looking for the next move in your career? Look no further.

My Client is currently looking for a Senior Study Start-Up Specialist to join their team in Belgium fully remotely! They are a Global Biotechnology company that was founded over 30 years ago, now with offices in Europe, America, Australia and more. They are consistently being recognised as one of the top places to work and to prove that they have been on the Science Magazine's 'Top Employers' list for over 10 consecutive years. With more than 60 clinical trials running globally, this opportunity will allow you to have an intense but pleasant experience all while learning from the best in the industry!

Responsibilities:

- Perform all kinds of Study Start Up activities including feasibility, site identification etc.
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS
- To be familiar with ICH GCP, relevant country regulations/guidelines, and SOPs
- Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable

Requirements:

- 2-4 years of experience of working in site start up (Pharmaceutical or CRO)
- Experience in Oncology studies is a essential
- Working knowledge of ICH-GCP guidelines, local and international regulatory requirements is essential
- Fluent in English, Dutch and French

If you think you could be the person for the job please apply here or alternatively on the NonStop Consulting website or contact me directly on my LinkedIn, Jakub Morszczyzna, by phone on +44 207 234 0550 ext. 3602 or E-Mail j.morszczyzna@nonstop-recruitment.com. If, however you feel like the job is not for you or you are not available, please feel free to share it with your friends / colleagues who could be interested and help out your network!

NonStop Consulting is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.

Senior Study Start-Up Specialist

Have you been working in Study Start Up and looking for the next move in your career? Look no further.

My Client is currently looking for a Senior Study Start-Up Specialist to join their team in Belgium fully remotely! They are a Global Biotechnology company that was founded over 30 years ago, now with offices in Europe, America, Australia and more. They are consistently being recognised as one of the top places to work and to prove that they have been on the Science Magazine's 'Top Employers' list for over 10 consecutive years. With more than 60 clinical trials running globally, this opportunity will allow you to have an intense but pleasant experience all while learning from the best in the industry!

Responsibilities:

- Perform all kinds of Study Start Up activities including feasibility, site identification etc.
- Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS
- To be familiar with ICH GCP, relevant country regulations/guidelines, and SOPs
- Perform regulatory document maintenance; amendments, periodic updates, and safety letters, where applicable

Requirements:

- 2-4 years of experience of working in site start up (Pharmaceutical or CRO)
- Experience in Oncology studies is a essential
- Working knowledge of ICH-GCP guidelines, local and international regulatory requirements is essential
- Fluent in English, Dutch and French

If you think you could be the person for the job please apply here or alternatively on the NonStop Consulting website or contact me directly on my LinkedIn, Jakub Morszczyzna, by phone on +44 207 234 0550 ext. 3602 or E-Mail j.morszczyzna@nonstop-recruitment.com. If, however you feel like the job is not for you or you are not available, please feel free to share it with your friends / colleagues who could be interested and help out your network!

NonStop Consulting is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.

Rejoignez une biotech de taille moyenne et développez de nouvelles compétences sur une nouvelle aire thérapeutique, sur laquelle peu de CRO, biotech et labos travaillent en France !

L'entreprise pour qui je recrute est à la recherche d'un chef de projet clinique senior. Cette société est une biotech avec un esprit start-up. Rejoignez une entreprise internationale travaillant sur une nouvelle aire thérapeutique ! Vous pourrez ainsi développer vos compétences dans ce domaine, ce qui sera un atout pour développer votre carrière professionnelle sur le long terme.

Responsabilités :

• Développer ou coordonner le développement et l'approbation de la documentation de l'étude
• Définir et piloter les échéanciers, les jalons et le budget des études
• Définir les besoins des fournisseurs de services
• Assurer un contrôle qualité approprié de tous les livrables
• Superviser l'élaboration des documents réglementaires
• Superviser le processus de faisabilité et de qualification du site
• Planifier, organiser et diriger la réunion de lancement, la réunion de l'enquêteur (le cas échéant) et la formation de l'ARC
• Effectuer la gestion continue du SP, suivre la gestion des performances et la résolution des problèmes
• Veiller à ce que la documentation d'étude appropriée soit conservée et archivée dans le TMF
• Fournir des mises à jour régulières sur l'état de l'étude
• Créer, gérer et assurer le suivi du budget de l'étude, y compris les révisions, et effectuer le rapprochement final à la clôture de l'étude
• Vérifier et approuver les factures SP et assurer un suivi et un rapprochement appropriés

Profil recherché :

• Bac + 5 ou équivalent en science de la vie ou en santé
• Minimum 5 ans d'expérience en tant que chef de projet clinique en biotech ou en CRO
• Expérience de monitoring sur site souhaité
• Fluent en anglais écrit et oral (parler plusieurs langues est un plus)
• Connaissance approfondie des directives de la Conférence internationale sur l'harmonisation (ICH) / Bonnes pratiques cliniques (BPC) et d'autres réglementations pertinentes en matière d'essais cliniques
• Quelqu'un capable de travailler dans un petit environnement
• Quelqu'un de souriant et d'énergique

Je me spécialise sur le recrutement des profils dans la recherche clinique en France et je serai heureux de pouvoir échanger avec vous.

Si vous pensez que le poste est fait pour, je vous invite à m'envoyer votre CV et votre lettre de motivation par mail à l'adresse suivante : m.bertholet@nonstop-recruitment.com

Project Manager

My client who is growing international software development company are looking for a Project Manager to join their team anywhere in Belgium. They have expanded massively in the last year and are continuing doing so this year. The client is offering a friendly atmosphere with very employee focused management team allowing for a long career with them and also the opportunity for progressing your career. They have multiple ongoing projects at the moment allowing you to gain different experiences as you go!

Responsibilities:

* Delivers projects, on time, budget, customer satisfaction and contractual obligations
* Gathers all information (completed tender, contract, identified risks...) necessary to set up an adequate project
* Identifies risks and assesses whether they could jeopardize project realization, manages risks and measures during project realization
* Ensures and maintains a good customer relationship while keeping in regular contact about status & progress

Requirements:

* Master degree or relevant work experience
* Experience in delivering software projects
* Experience implementing LIS or LIMS as a user or implementer in hospitals or private laboratories is a plus
* Fluent in Dutch & English

If you think you could be the person for the job please apply here or alternatively on the NonStop Consulting website or contact me directly on my LinkedIn, Jakub Morszczyzna, by phone on +44 207 234 0550 ext. 3602 or E-Mail j.morszczyzna@nonstop-recruitment.com. If, however you feel like the job is not for you or you are not available, please feel free to share it with your friends / colleagues who could be interested and help out your network!

NonStop Consulting is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.

WMA Governance Director

My client who is a massive multi-national pharmaceutical company based in Switzerland are looking for someone to join their team as a WMA Governance Director on a 12 month contract based in the office in Basel. Although this will be a contract my client is looking for long term collaboration so even as a contractor there is still the option of a promotion and being able to build a career, all while enjoying the benefits of contracting!

Responsibilities:

* Lead End-to-End medical governance of evidence generation activities in assigned geographical area of responsibility
* Monitor adherence to clients processes and standards
* Provide input to teams decision making, prioritization of initiatives and drive consistent rollout of global medical compliance and governance initiatives.
* Act as the expert and first point of contact for country MGLs
* Provide governance updates to Regional Medical Head as required.

Requirements:

* Extensive & Relevant experience in Medical Affairs and/or Clinical Development of Medicines (7-10 years)
* Knowledge & Understanding of both scientific & operational aspects of Clinical Drug Development and Medical Affairs
* Knowledge & Understanding of ICH GCP and respective national/supranational regulations in assigned geographical area of responsibility.

If you think you could be the person for the job please apply here or alternatively on the NonStop Consulting website or contact me directly on my LinkedIn, Jakub Morszczyzna, by phone on +44 207 234 0550 ext. 3602 or E-Mail j.morszczyzna@nonstop-recruitment.com. If, however you feel like the job is not for you or you are not available, please feel free to share it with your friends / colleagues who could be interested and help out your network!

NonStop Consulting is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.

Site Management Associate

Are you a Clinical Trial Assistant who is looking to make their next step? Or maybe a Clinical Trial Associate who is tried of constantly being on the road? My client is currently looking to take on a Site Management Associate to join their team in the Netherlands or in Belgium. They are a Global CRO located in over 40 countries and are very employee focused - not only offering fantastic packages but also recognition programs. They are looking at developing not only their company but also their employees on the way.

Responsibilities:

* Support the management of investigative sites and ensure that all sites adhere to the requirements and regulations governing Clinical Research
* Working closely with Clinical Team Managers, Start-Up Leads and Clinical Research Associates
* Working within the framework of the study protocol, to assist with the preparation and organisation of investigator and study site materials both at a local and international level
* Essential document collection, review and maintenance

Requirements:

* Degree in Scientific field / have equivalent work experience
* Understanding of ICH-GCP guidelines as well as local and international regulatory requirements
* Experience in start-up, site activation, Ethics Committee Submissions
* Fluent in English & Dutch (French is a bonus!)

If you think you could be the person for the job please apply here or alternatively on the NonStop Consulting website or contact me directly on my LinkedIn, Jakub Morszczyzna, by phone on +44 207 234 0550 ext. 3602 or E-Mail j.morszczyzna@nonstop-recruitment.com. If, however you feel like the job is not for you or you are not available, please feel free to share it with your friends / colleagues who could be interested and help out your network!

NonStop Consulting is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.