Ctms System Specialist
il y a 4 jours
**CTMS System Specialist**
We have current opportunities for a CTMS System Specialist in Europe Join our growing team.
Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
**We offer flexible location options, and remote based working**. This position can be based in one of the following countries: UK, France, Spain, Italy, Germany, Belgium, Netherlands, Poland, Hungary, Serbia. Romania, Slovakia.
**Position Summary**:
**Essential functions of the job include but are not limited to**:
- Assist with new version releases and configuration changes, including development, testing, and validation oversight or as needed User Acceptance Test (UAT) execution.
- Collaborate with study team leads to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including: countries and sites; grant access for internal, sponsor and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report & letter templates and baseline milestones
- Work with data management and clinical programming to establish potential for integration with EDC.
- Manage end-user and group permission settings.
- Provide adequate training of system functionality to study teams, including external partners, sponsor and/or site staff, to ensure that study teams have the guidance needed to work CTMS features independently and meet periodically with study teams to offer ongoing support.
- Create and/or provide input for the creation of work instructions/job aids, assess global & project specific trip report & letter templates, assist teams with workflows and provide training materials/tools as needed.
- Continually assess that CTMS features are functioning properly and efficiently; track all issues & observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.
- Integrate CTMS activities in line with integrations with the corresponding eTMF as necessary.
- Clinical Trial Management duties (as needed):
- Create and manage study timelines and milestones.
- Assist with the site status.
- Entry of monitoring visits, study activities, deviations, assist with trip report workflows, develop activity plans, etc.
- Monitor completeness and quality of the CTMS (from start up to final deliverable).
- Perform periodic reviews to ensure CTMS adoption and progress is timely and in line with the current stage of each program.
**Qualifications**:
**Minimum Required**:
- Bachelor's Degree preferred.
- 4+ years of Clinical Systems team experience within a CRO is highly preferred.
**Other Required**:
- 2+ years CTMS or other clinical program management system(s) experience
- Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
- Extensive knowledge of monitoring and site management; some knowledge of study management and reporting needs.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
**Preferred**:
- Working knowledge of and experience with Medidata Rave CTMS
- Working knowledge of and experience with TransPerfect Trial Interactive eTMF
- Proficient in MS Excel
- Some experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms
- MS project or other GANTT charting and milestone development is a plus
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
Pr
-
Local Ctm- Belgium
Il y a 7 mois
Brussels, Belgique Thermo Fisher Scientific Temps pleinAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Cta
Il y a 7 mois
Brussels, Belgique Science Talents Temps plein**Introduction**: Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key. We are very open and communicative go-getters who are keen on results and quality. To further strengthen our...
-
Support Cta
Il y a 7 mois
Brussels, Belgique Oxford Global Resources Temps plein**Support CTA (EN - DU/FR)**: - Location: Brussels, Belgium - Contact: Aurelie Petit - Job type: Permanent - Contact phone: +32 25 88 16 02 - Industry: Clinical Research You have a first experience in the Clinical Research field ? You are fluent in Dutch OR French and English ? Then this position at one of our big pharma clients may be just for you! For a...
-
Support Cta
Il y a 7 mois
Brussels, Belgique Oxford Global Resources Temps pleinLocation: Brussels, Belgium - Contact: Aurelie Petit - Job type: Permanent - Contact phone: +32 25 88 16 02 - Industry: Clinical Research You have a first experience in the Clinical Research field ? You are fluent in Dutch OR French and English ? Then this position at one of our big pharma clients may be just for you! For a multinational pharmaceutical...
-
Operating System Deployment Specialist
Il y a 7 mois
Brussels, Belgique Doesburg.biz Temps plein**Join the Future of Tech in Brussels!** Ready to make a significant mark in the world of operating systems and deployment? We're in search of a visionary to steer our technological transformation in Brussels. **Position**: Operating System Deployment Specialist **Skills You'll Bring**: - Mastery in Java, Agile, JSON, Spring, Maven, SQL, and more. -...
-
System Specialist Microsoft
il y a 3 semaines
Brussels, Belgique Infrabel Temps plein**LE TRAVAIL** - En tant que spécialiste des systèmes ICT pour les produits Microsoft, vous êtes responsable de la conception, du développement et de la maintenance opérationnelle des systèmes afin de garantir l'accessibilité, les performances, la sécurité et la stabilité des activités d'Infrabel via ces systèmes. Vous jouez un rôle crucial dans...
-
System Specialist
Il y a 3 mois
Brussels, Belgique Medtronic Temps pleinAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life **:We are looking for a System Specialist to join our team. Is this the challenge you have...
-
Power System Data Specialist
Il y a 7 mois
Brussels, Belgique Apollo Solutions Temps pleinBrussels â" hybrid working (2 days per week on-site) **Salary**: â¬70-75k + benefits + bonus!  My growing Energy client is looking for a skilled Power System Data Specialist to join their growing team in Brussels on a hybrid working pattern.  **Power System Data Specialist Responsibilities**: Responsible for the product management,...
-
Local Start-up Specialist
Il y a 7 mois
Brussels, Belgique Allucent Temps pleinAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Local Start Up Specialist II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and...
-
Supply Chain Systems Specialist
Il y a 7 mois
Brussels, Belgique JACOBS DOUWE EGBERTS Temps pleinSupply Chain Systems Specialist - Supply Chain - Brussels - Full-time - Belgium You are a brand lover. You want to be in the driving seat and to impact. You want to work with a multi-cultural team where diversity is valued for what it brings - divergence of opinions that makes our life and business richer. You want to create amazing coffee moments for...
-
Safety Management Systems Specialist
Il y a 7 mois
Brussels, Belgique Infrabel Temps plein**LE TRAVAIL**: Chez Customer & Business Excellence, nous gérons toutes les tâches opérationnelles et liées à la clientèle au sein de notre entreprise de manière à soutenir la stratégie globale de notre entreprise. En tant que spécialiste des systèmes de gestion de la sécurité, vous gérerez et maintiendrez le système de gestion de la...
-
Supply Chain System Specialist
il y a 1 semaine
Brussels, Belgique JACOBS DOUWE EGBERTS Temps pleinSupply Chain System Specialist - Supply Chain - Bruxelles - Full-time - Belgium Vacatureomschrijving Krijg je energie van het leggen van de brug tussen business en technologie? Krijg je energie van het optimaliseren van processen en het oplossen van problemen? Heb je IT-savvy met sterke analytische vaardigheden? Heb je een "can do" mentaliteit? En geniet...
-
Cra Ii
Il y a 7 mois
Brussels, Belgique Thermo Fisher Scientific Temps pleinCRA II / Sr CRA - Belgium At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...
-
System Administration
il y a 1 semaine
Brussels, Belgique HNM Solutions Temps plein**Job ID: HNMJD1630**: **Role: System Administration** **Locations: Brussels,Belgium** - SMT: Helpdesk tool based on Micro Focus Service Manager 9.64 - MY IT Support (MITS): Self-service web-based tool for registering standard requests and incidents (the web portal of SMT) - ServiceNow: The ServiceNow is a SaaS cloud computing software. It involves setting...
-
Dri - Gestionnaire Système
il y a 3 semaines
Brussels, Belgique Federale Politie Temps pleinNiveau d'études - Secondaire supérieur- Degré - Assistant-ICT - Lieu d'embauche - DRI - SERVICES Rue Royale 202 A, 1000 Bruxelles - Date limite d'inscription - 10.01.25 - Nombre maximum d'inscriptions - 25 - Numéro de référence - 117886/S6T **Description d'emploi**: Ses tâches sont multiples et variées. Elles comprennent principalement...
-
Supply Chain Systems Specialist
Il y a 7 mois
Brussels, Belgique JACOBS DOUWE EGBERTS Temps pleinYou are a brand lover. You want to be in the driving seat and to impact. You want to work with a multi-cultural team where diversity is valued for what it brings - divergence of opinions that makes our life and business richer. You want to create amazing coffee moments for consumers through brands like Douwe Egberts, Jacqmotte, L’Or or Senseo. Then this...
-
Responsable Des Opérations Ferroviaires Et de
Il y a 6 mois
Brussels, Belgique HR-Specialist Temps plein**A propos de l’entreprise**: - Notre client est un **acteur majeur** dans le domaine des **transports **de personnes en Europe. Au quotidien ce sont plus de 2000 employés qui grâce à leur travail permettent à des familles, des collègues, des amis de se retrouver en quelques heures. C’est aussi une entreprise **green **qui joue un rôle essentiel...
-
System Integration
Il y a 7 mois
Brussels, Belgique The White Team Temps plein**System Integration & Workplace Specialist - Brussels - EU Public Organisations** **1. CONTEXT/INTRODUCTION** **2. DESCRIPTION OF THE TASKS** Following tasks will be performed by external service provider: - Design, plan, implement integration strategies and patterns in a JEE/HTTP secured ecosystem. - Design and document APIs to be exposed in a secured...
-
System Administrator
il y a 6 jours
Brussels, Belgique Recruit4.work Temps plein**Responsibilities**: - The principal function, using his experience on ServiceNow Platform, will be to help and guide the service in the context of the maintenance or continuous deployment and improvements of the ServiceNow Platform solution (principally on ITSM module) **Required experience and skills**: - Languages: very good English and French (verbal...
-
System Integration
Il y a 7 mois
Brussels, Belgique Serco Europe Temps pleinJob Introduction Serco is the preferred partner for European Institutions and International Organizations, offering flexible ICT services and Contact Centre management across Europe. Our expertise extends from Information System support to consultancy under the DIGIT TM framework, supporting key entities such as the European Commission and Executive...
