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Health coordinator • elze

Zuletzt aktualisiert: vor 1 Tag
(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
  • Gesponsert
Business Developer New Food (m / w / d)

Business Developer New Food (m / w / d)

GEA TDS GmbHSarstedt, Germany
GEA is one of the largest suppliers for the food and beverage processing industry and a wide range of other process industries. Approximately 18,000 employees in more than 50 countries contribute si...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Product Line Manager (m / f / d)

Product Line Manager (m / f / d)

Kelvion Holding GmbHSarstedt, Niedersachsen, Deutschland
Quick Apply
Product Line Manager (m / f / d) at Kelvion Holding GmbH | softgarden.Karl-Schiller-Straße 1-3, 31157, Sarstedt.At Kelvion, our mission is to lead the industrial transformation by championing innovatio...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
MFA / Medizinische Fachangestellte (m / w / d)

MFA / Medizinische Fachangestellte (m / w / d)

FRESENIUS_HELIOS_HOSPITALSElze
Sie wissen, was Sie können? Ihr Talent braucht die richtige Umgebung! Starten Sie mit uns in Ihre Zukunft!.Zur Verstärkung unseres Praxisteams im Medizinischen Versorgungszentrum am Standort Elze s...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
R&D Coordinator OEM (m / w / d)

R&D Coordinator OEM (m / w / d)

Dr. Heimeier Executive SearchNiedersachsen
Unser Mandant ist ein erfolgreicher, global aufgestellter Zulieferer der Automobilindustrie mit mehreren tausend Mitarbeitenden und Werken in Europa, Asien und Nordamerika.Die Gruppe mit Stammsitz ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Test Development Engineer

Test Development Engineer

ic resourcesLower Saxony, Germany
Unbefristet
Are you passionate about pioneering technologies that shape the future? Our client, a global leader in innovative solutions from materials to systems, Our client is at the forefront of empowering m...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Engineer Plate Development (m / f / d)

Engineer Plate Development (m / f / d)

Kelvion PHE GmbHSarstedt, Niedersachsen, Deutschland
Quick Apply
Engineer Plate Development (m / f / d) at Kelvion PHE GmbH | softgarden.Engineer Plate Development (m / f / d).Karl-Schiller-Straße 1-3, Sarstedt. At Kelvion, our mission is to lead the industrial transform...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Außendienst Sales Manager (m / w / d) Digital Health - Hannover

Außendienst Sales Manager (m / w / d) Digital Health - Hannover

Sidekick Health Germany GmbHNiedersachen, Niedersachsen, DE
Außendienst Sales Manager (m / w / d) Digital Health im Raum Hannover.Head of Sales und unserem wachsenden Sales Team, neue Kunden für unsere Digital Health Produkte. Du führst in deinem Vertriebsgebiet...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
HR&GS Coordinator(Stade,Germany)

HR&GS Coordinator(Stade,Germany)

Tecnicas ReunidasBaja Sajonia, Alemania
Coordinate with HR department Home Office Madrid the personnel mobilizations of different departments : date of arrival, welcome. Help and support to our team in Stade with Major registrations and re...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Customer Service Advisor with German in Sofia, Bulgaria (with relocation)

Customer Service Advisor with German in Sofia, Bulgaria (with relocation)

Cross Border TalentsLower Saxony, Germany
Quick Apply
Looking to grow your career with a global leader in technology and services? We collaborate with some of the most renowned brands worldwide, enhancing their businesses with cutting-edge solutions.W...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
(Junior) Recruiting & Employer Branding Manager (m / w / d)

(Junior) Recruiting & Employer Branding Manager (m / w / d)

L'OsteriaNiedersachsen, Deutschland
Quick Apply
Junior) Recruiting & Employer Branding Manager (m / w / d).Junior) Recruiting & Employer Branding Manager (m / w / d) ~.Hast Du Lust, in einem dynamischen und innovativen Umfeld deine Karriere vora...Mehr anzeigenZuletzt aktualisiert: vor 13 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.