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Sustainability engineer • uchte

Zuletzt aktualisiert: vor 4 Tagen
(Sr.)CRA Germany

(Sr.)CRA Germany

Edwards LifesciencesGermany, Niedersachsen, Remote
Homeoffice
Vollzeit
CRA II or SCRA (ideally with minimum of 3 years experience of monitoring) based in Germany or other environs.Is capable of conducting SIVs, IMVs and COVs independently. Has a solid working knowledge...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Data Engineer (Remote)

Data Engineer (Remote)

TechBiz Global GmbHHalle, ST, DE
Homeoffice
About TechBiz Global TechBiz Global is a leading recruitment and software development company.Our diverse, globally distributed team provides IT recruitment, outstaffing, outsourcing, software deve...Mehr anzeigenZuletzt aktualisiert: vor 10 Tagen
Senior Verification Engineer

Senior Verification Engineer

ic resourcesLower Saxony, Germany
Unbefristet
Senior Verification Engineer - Lower Saxony - leading optical communications company.A global leader in opto-electronic applications for industrial, optical communications, aerospace and defence, l...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Mitarbeiter (m / w / d) Nachhaltigkeitsreporting

Mitarbeiter (m / w / d) Nachhaltigkeitsreporting

Follmann Chemie GmbHPetershagen
Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
System Test Engineer (m / w / d)

System Test Engineer (m / w / d)

HaysNiedersachsen
Anstellung bei der Hays Professional Solutions GmbH Niedersachsen Startdatum : sofort Referenznummer : 716632 / 1.Diesen Job teilen oder drucken. Entwurf von Testsystemen und Testkonfiguration (SIL, HIL...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Cloud Engineer - AWS (m / w / d)

Senior Cloud Engineer - AWS (m / w / d)

Liebherr GroupKirchdorf
Bei der Liebherr-IT Services GmbH legen wir Wert auf die Entfaltung individueller und unternehmerischer Bedürfnisse und leben daher das Flex Office : Wir arbeiten im hybriden Modell bei flexiblen Ar...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
German Speaking Junior Campaign Specialist in Barcelona

German Speaking Junior Campaign Specialist in Barcelona

Cross Border TalentsLower Saxony, Germany
Vollzeit
Quick Apply
Are you a Google fan? Do you love Google products?.Are you passionate about the web and new technology?.If you are tech-savvy, creative, outgoing, and willing to roll up your sleeves and get things...Mehr anzeigenZuletzt aktualisiert: vor 22 Tagen
  • Gesponsert
Cloud-Engineer Microsoft Azure / Azure AD (a •)

Cloud-Engineer Microsoft Azure / Azure AD (a •)

Hamburger Energienetze GmbHSittensen, Germany
Betrieb und Optimierung der Microsoft Azure Cloud-Infrastruktur.Sicherstellung einer effizienten Nutzung von Azure-Ressourcen, einschließlich Identity und Access Management (IAM) über Entra ID.Tech...Mehr anzeigenZuletzt aktualisiert: vor 4 Tagen
  • Gesponsert
Electrical Engineer or Computer Scientist (m / f / d) in Technical Support / Automation Technology

Electrical Engineer or Computer Scientist (m / f / d) in Technical Support / Automation Technology

ABBPetershagen, DE
Electrical Engineer or Computer Scientist (m / f / d) in Technical Support / Automation Technology.At ABB, we are dedicated to addressing global challenges. Our core values : care, courage, curiosity, an...Mehr anzeigenZuletzt aktualisiert: vor 11 Tagen
  • Gesponsert
Graduate Field Applications Engineer - Analog and Mixed-Signal mfd

Graduate Field Applications Engineer - Analog and Mixed-Signal mfd

Renesas ElectronicsGöttingen, Lower Saxony, Germany
We are looking for an enthusiastic and dynamic Field Applications Engineer (FAE) to support our automotive customers in EMEA area focusing on analog and mixed signal products.As a Field Application...Mehr anzeigenZuletzt aktualisiert: vor 21 Tagen
Vertriebsmitarbeiter / Sales Engineer Steuerungstechnik (m / w / d)

Vertriebsmitarbeiter / Sales Engineer Steuerungstechnik (m / w / d)

TROVA Personal- und ManagementberatungDiepenau, Niedersachsen, DE
Das Unternehmen ist Teil der HAHN Group, einem global agierenden Hidden Champion der Automatisierungs- und Robotertechnik. Für das weitere und nachhaltige Wachstum suchen wir für die Abteilung Custo...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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(Sr.)CRA Germany

(Sr.)CRA Germany

Edwards LifesciencesGermany, Niedersachsen, Remote
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
  • Homeoffice
Stellenbeschreibung

CRA II or SCRA (ideally with minimum of 3 years experience of monitoring) based in Germany or other environs. Is capable of conducting SIVs, IMVs and COVs independently.

Has a solid working knowledge of the regulatory environment : ISO, MDR and GCP.

Is familiar with maintaining ISFs and the study e TMF.

Background in pharma or medical devices.

Experience in cardiology / cardiac therapy clinical trials.

Ideal locations : North or Central Germany

Responsible for remotely supporting field clinical research associate / site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities :

  • Organizing and supervising clinical study :

o Assist and conduct Clinical Monitoring activities

o Serve as key contact to assigned clinical sites throughout the study process

o Is accountable for achieving and reporting on agreed clinical milestones

o Supports study team in the interactions with Ethics Committees and Competent Authorities

o Participates actively to project team meetings, as required

o Close collaboration with internal stakeholders to ensure proper project conduct

o Assist in Providing site and Edwards personnel training including preparation / maintenance of study documents, completion of forms, understanding of examinations / assessments required

o Reporting site enrollment progress including device accountability and protocol deviations (inclusion / exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.

  • Processing adverse events
  • o Document procedural case observations for insights in investigating post procedural events

    o Data review, safety reporting and complaint handling

    o Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements

  • Identifies and supports process improvement opportunities and implementation
  • Ensures Audit readiness for internal, external and site Audits
  • Other incidental duties as assigned by management
  • Education and Experience :

    Bachelor's Degree in in related field ,3 years experience of previous related medical device and / or clinical experience Required

    Other : 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 and

    Other : Experience in interventional cardiology or cardiothoracic surgery Preferred

    Additional Skills :

  • Good computer skills in MS Office Suite and ability to operate general office machinery
  • Good written and verbal communication skills, presentation and interpersonal relationship skills
  • Good 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 environment and prevention of pollution under their span of influence / control
  • What is it like to work at Edwards Lifesciences in Germany?

    As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

    We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

    Edwards Lifesciences in Germany also offers the following benefits :

  • Competitive Compensation and Benefits package
  • Flexible working hours, remote working
  • Pension plan Risk
  • Insurance Meal Benefits
  • Service Awards Enhanced
  • Leave Benefits
  • Transportation Benefits
  • Employee Stock Purchase Programme
  • Employee Assistance Programme
  • Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.
  • Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.