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Delivery lead • breuberg

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Sr. Clinical Research Associate

Sr. Clinical Research Associate

AvaniaHesse, DE
Vollzeit
Avania is hiring Senior Clinical Research Associates (Sr CRAs) .Avania’s ClinOps Team establishes, maintains and supports clinical trials. as a key member of the team, our Sr CRA pe...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director Legal Compliance EMEA

Director Legal Compliance EMEA

CarrierHesse, Germany
Viessmann Werke Allendorf GmbH, Viessmannstraße 1, 35107 Allendorf (Eder), Germany.Director Legal Compliance EMEA.Rueil-Malmaison, France or Allendorf, Germany. Carrier is the leading global provide...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
R&D Director (PhD in chemistry with professional experience) – Polymer Materials Development (all genders)

R&D Director (PhD in chemistry with professional experience) – Polymer Materials Development (all genders)

D007 CIBA Vision GmbH CompanyGrosswallstadt, Germany
At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress and act with speed as the global leader in eye care.Here, you’ll be recogni...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
Customer Success Manager

Customer Success Manager

GTT Communications, Inc.DE Frankfurt, Neu, Isenburg
Vollzeit
Hybrid -Dusseldorf, Frankfurt, Munich, Geneva or Zurich.GTT is a leading networking and security as a service provider for multinational organizations, simply and securely connecting people and mac...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
Director RWD Scientist

Director RWD Scientist

SEC Life SciencesHessen
Unbefristet
Are you ready to shape the future of healthcare through cutting-edge data analytics? We are seeking a dynamic.Director, Real World Data (RWD) Scientist. This is an exciting opportunity to leverage y...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Customer Onboarding Manager (f / m / d)

Customer Onboarding Manager (f / m / d)

SYNCREONElsenfeld, HE, DE
Put simply, DPW Logistics helps e-commerce companies stress less and grow more.We offer a full suite of fulfillment solutions for our merchants, including the ability to improve their transit times...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
EHS Lead (m / w / d)

EHS Lead (m / w / d)

KerryKleinheubach, BB, DE
Unbefristet
Als EHS-Lead (Environmental, Health, and Safety) du bist für die Beaufsichtigung und Verwaltung der EHS-Programme und -Initiativen verantwortlich. Darüber hinaus bietest du Schulungen an, leitest Un...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Program Manager, Hessen

Program Manager, Hessen

Axiom Software SolutionsHessen, Germany
Program ManagerRole : Program Manager Location : Frankfurt Germany (Hybrid) Type : Permanent OR Contract Salary : As per market Contract Rate : As per market Must be fluent German and English...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
BlackBerry QNX Principal Technical Project Manager (Automotive & GEM)

BlackBerry QNX Principal Technical Project Manager (Automotive & GEM)

QNX Software SystemsHesse, Germany
Vollzeit
BlackBerry® QNX® is a trusted supplier of safe and secure operating systems, hypervisors, frameworks and development tools, and provides expert support and services for building the world’s most cr...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Regional Business Manager (gn) Biosimilar

Regional Business Manager (gn) Biosimilar

Inizio Engage XDThüringen und Teile von Hessen
Als global führendes Unternehmen arbeiten wir in den Bereichen Beratung, Healthcare Communications, kommerzielle Dienste, Patientenlösungen und Medical Affairs eng mit unseren Kunden zusammen.Mitar...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Produktionsmitarbeiter (m / w / d, Vollzeit, vollkontinuierliches Schichtsystem)

Produktionsmitarbeiter (m / w / d, Vollzeit, vollkontinuierliches Schichtsystem)

RöchlingBrensbach
Vollzeit
Eigenständige optische Prüfung der Bauteile und Dokumentation der Fehler.Verpackung der Bauteile und Etikettierung der Verpackungseinheiten. IST-Meldung der gefertigten Teile über ein ERP-System.Erf...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
SOC Analyst

SOC Analyst

Motion RecruitmentHesse, Germany
Job Description Our client, a leading European cyber consulting firm, is expanding into Vancouver, and we're searching for a proactive and driven SOC Analyst to join their team as their first Canad...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Mitarbeiter (m / w / d) Marketing Online & Design 20-30h TZ

Mitarbeiter (m / w / d) Marketing Online & Design 20-30h TZ

Page PersonnelDarmstadt-Dieburg, Deutschland
Hervorragende Einarbeitung in einem tollen Team mit guter Unternehmenskultur.Work-Life-Balance und betriebliche Altersvorsorge. Unser Unternehmen ist ein etablierter Marktführer in der Machinenbaubr...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Named Account Executive - Insurance

Named Account Executive - Insurance

DatabricksHesse, Germany
This is a remote role and can be based anywhere in Germany • •.Databricks operates at the leading edge of the Unified Data Analytics and AI space. Our customers turn to us to lead the accelerated inno...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Sr. Clinical Research Associate

Sr. Clinical Research Associate

AvaniaHesse, DE
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

Avania is hiring Senior Clinical Research Associates (Sr CRAs)

Avania’s ClinOps Team establishes, maintains and supports clinical trials; as a key member of the team, our Sr CRA performs clinical trial oversight for the trials, verifying that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable (from source documents). Partnering closely with our Trial sites, Avania's Sr CRA ensures that the conduct of the trial follows approved protocols / amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Our Senior CRA role includes the following key activities -

  • Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects.
  • Monitor site’s completion of action items between visits and help prepare for audits and inspections; conduct and write accurate visit reports in accordance with SOPs and GCP (SQV, SIV, IMV, COV)
  • Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
  • Participate in internal TMF reviews, as needed.
  • Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
  • Review and write informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to site and study sponsor.
  • Review regulatory compliance for study documents and protocols.
  • May act as a Clinical Lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites).

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.

Sr CRAs require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution.

We seek -

  • B.A. / B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
  • Minimum 3-7 years of relevant CRA work experience, with extensive cardiology Class III device monitoring experience.
  • Tracker and Start-up experience (with good spreadsheet or similar skills)
  • Ability to understand basic and complex medical details.
  • GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of / ability to learn regulations and guidelines on medical devices and clinical trials.
  • Ability to travel up to 75% domestically and internationally.
  • Experience as a Clinical Lead helpful
  • Strong communicator with excellent presentation skills; able to build rapport with site personnel
  • We offer -

  • The opportunity to work in an innovative, fast-growing and rewarding industry
  • A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
  • Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
  • Competitive compensation and benefits package (details shared during the interview process)
  • Some roles offer the opportunities for travel
  • Ask us about our hybrid and fully remote work opportunities
  • We look forward to receiving your application!

    When you need to advance your career, it takes Avania!

    LI-DNI