Lead CRA, null
il y a 3 semaines
Social network you want to login/join with:
- Organizing and supervising clinical study:
- Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts). Assist with resolving, identifying of problems including background and actions to prevent reoccurrences.
- Assist and conduct Clinical Monitoring activities as required
- Serve as key contact to assigned clinical sites throughout the study process and is accountable for achieving and reporting on agreed clinical milestones.
- Supports study team in the interactions with Ethics Committees and Competent Authorities.
- Participates actively in project team meetings, as required.
- Close collaboration with internal stakeholders to ensure proper project conduct.
- Assist in providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required.
- Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment).
- Collecting completed Case Report Forms (CRF) and collecting, confirming, and auditing supporting documentation.
- Processing adverse events.
- Document procedural case observations for insights in investigating post-procedural events.
- Data review, safety reporting, and complaint handling.
- Ensure regulatory and clinical protocol compliance is maintained, including but not limited to:
- Maintaining appropriate regulatory documents both internally and externally.
- Adverse events and protocol deviations are reported in a timely manner.
- Ensure device complaints and malfunctions are reported.
- Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements.
- Develop new improved processes and perform implementation.
- Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study-related activities.
- Ensures audit readiness for internal, external, and site audits.
- Acts as a mentor to new or junior level employees.
- Other incidental duties as assigned by line management, leadership, or by Clinical Trial Management.
Education and Experience:
- Bachelor's Degree in a related field, 5 years experience of previous related medical device and/or clinical experience required, or
- Associate's Degree or equivalent in a related field, 7 years experience of previous field monitoring experience, quality assurance/control, and regulatory compliance required.
- Experience working in a medical device or regulated industry and experience with electronic data capture is necessary.
- Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) preferred.
- Experience in interventional cardiology or cardiothoracic surgery preferred.
- Agile, dynamic, solution-focused traits are preferred.
Additional Skills:
• Proven expertise in MS Office Suite and ability to operate general office machinery.
• Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills.
• Excellent problem-solving and critical thinking skills.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
-
Lead Engineer, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:As a Lead Engineer, you will play a key role in the preparation and execution of our offshore projects. You will collaborate with employees of different nationalities and disciplines and you will be located at our HQ. We are currently looking for an experienced Lead Engineer who can manage (large) offshore cable...
-
HR Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:A job at Proximus? You'll find that everything revolves around the idea 'Think Possible'. This means: we always assume that something is possible, even if it seems impossible. Well, especially so, actually. Call it a way of thinking that involves being open to a world of digital solutions that make our lives easier....
-
Chef de Projet Méthodes Junior H/F, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinChef de Projet Méthodes Junior H/F, nullDescription de l'entrepriseFondé à Lille il y a plus de 13 ans, le Groupe ELYSIS (200 collaborateurs et 18 millions d'euros de Chiffre d'Affaires en 2023) accompagne les directions techniques de plus de 130 groupes industriels nationaux et internationaux.Le succès d'Elysis et de ses équipes s'est d'abord construit...
-
Lead Sales Specialist, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinPour le département Marketing, nous recherchons un(e) Lead Sales Specialist.Vous êtes à la recherche d'un nouveau défi où vous pourrez mettre à profit votre créativité et votre pouvoir de persuasion ? Au sein de notre département marketing « Telemarketing », nous offrons un poste commercial plein de passion et de dynamisme, principalement axé sur...
-
Project Leader 3XP-Construction durable
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinProject Leader 3XP-Construction durable, nullIntégrez une équipe innovante dans la construction durable Êtes-vous passionné(e) par la construction et l'innovation durable ? Nous avons une opportunité exceptionnelle pour vous Nous recherchons un(e) Project Manager expérimenté(e) pour rejoindre une entreprise en plein essor spécialisée dans les...
-
Senior Associate
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Senior Associate (2025 PhD/ABD graduates) (Competition practice)Job Reference:9a092416aed3Job Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:About Charles River AssociatesCharles River Associates (CRA) is a leading global consulting firm that offers economic, financial, and strategic expertise to...
-
API Testing Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinVoor onze klant met meerdere filialen, zijn wij op zoek naar een API Testing Lead. Ze zijn gespecialiseerd in testings en cyberbeveiliging voor softwaresystemen en apparaten.Wat zal jij doen als API Testing Lead?Je zal verantwoordelijk zijn voor het leiden van de API-testinspanningen en ervoor zorgen dat onze API's voldoen aan functionele, prestatie -en...
-
Lead Software engineer, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinDans le cadre du développement de l'un de nos clients, nous recherchons un lead software engineer. En tant que Lead Software Engineer, votre tâche principale consiste à prendre le lead technique d'une équipe de développeurs.Vos responsabilités:Apporter votre expertise technique.Former, coacher et accompagner les développeurs.Analyser le cahier des...
-
IT Product Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinAu sein d'AXA Belgique, le département IT P&C est responsable de la gestion quotidienne, de la sécurité, de l'évolution technique et fonctionnelle des applications et systèmes d'assurance P&C (incendie, automobile, risques divers) pour nos clients, partenaires, courtiers ou employés.Le département IT P&C cherche à nommer un IT Product Lead, chargé...
-
Commercial Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social...
-
Lead Developer Belgie, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Starters Job Belgium, Wemmel Sales BelgiumExact is op zoek naar een Business Developer die verantwoordelijk is voor het genereren van leads via verschillende kanalen, zoals telefonisch (In en Outbound), e-Mail, Chat en LinkedIn. Dit is een Marketing-/Salesfunctie met een onbeperkt potentieel aan...
-
Senior Sales Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Expleo is looking for a Senior Sales Lead. Are you motivated about driving business in a high added value service environment? If you are passionate about sales, possess a strategic mindset, and have a proven track record of driving revenue growth, we want to hear from you Does our mantra "think bold, act reliable"...
-
Lead Engineers Cables, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinAs a Lead Engineer, you will play a key role in the preparation and execution of our offshore projects. You will collaborate with employees of different nationalities and disciplines and you will be located in our Breda offices. We are currently looking for an experienced Lead Engineer who can manage (large) offshore cable installation projects, having both...
-
Cost Engineering Leader, null
il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSoucieux de fédérer toutes les forces vives autour de nos projets d'avenir, nous recherchons un(e):Cost Engineering Leader (H/F)Direction opérationnelleVotre mission :En tant que Cost Engineering Leader au sein du département des opérations vous êtes responsable de la détermination des coûts de production de nos produits (slat, flap, fuselage, …)....
-
Teamleader Customer Care
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinTeamleader Customer Care (avec Télétravail), nullEn tant que Coordinateur service clientèle, vous aurez les responsabilités suivantes :Diriger et motiver une équipe dédiée à la satisfaction du client ;Superviser et gérer les performances de l'équipe afin d'atteindre les objectifs fixés ;Fournir un soutien et une assistance aux membres de l'équipe...
-
IT Lead Architect, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Join a well known brand within IT ServicesFlexible working optionsThe JobLocation: Brussels, Belgium (Hybrid - 2 days a week in the office)Job Description:As an IT Lead Architect, you will be part of the tactical team Enterprise IT Services. You will ensure the availability of the Federal Pension Service's reference...
-
Lead Python Developer, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Sportserve forms part of a remarkable group of B2C sports betting and B2B sportsbook technology companies, focused on delivering first-class sports betting experiences and casino products for our users worldwide. Along with Sportion, TechSpirit, Standard Focus, and Sportelligent, we are the driving force behind the...
-
Domain Lead – Risk, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinAs the Risk Expert at YPTO, you will be responsible for overseeing the organization's risk management process, providing guidance to the Risk team, and ensuring continuous improvement. Additionally, you will act as an authority in developing, implementing, and maintaining the risk management framework in alignment with academic theories, industry standards,...
-
Client HR Tech Lead, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Your candidacy is currently being considered for a requisition for an Alight Inc group company. As you may be aware, Alight has announced intent to divest its Payroll & Professional Services business to HIG Capital. After the transaction closes, this position will be aligned to the new Payroll & Professional...
-
Senior Leader, Logistics Europe, null
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps pleinSocial network you want to login/join with:About RHRH at its core is about taste, and we believe the idea of scaling taste is large and far reaching. The RH brand attracts the best designers, artisans, manufacturers, and talent in our industry, scaling and rendering their work more valuable across our integrated platform, enabling us to curate the most...
