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Research assistant • cham

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Lead Clinical Research Associate.

PSIZug, Suiza
Homeoffice

Coordinates investigator/ site feasibility and identification process, as well as study startup.Monitors project timelines and patient enrollment, implements respective corrective and preventive me...Mehr anzeigen

Assistant Key Account Manager D/F 100% (m/w/d)

Universal-Job AGRotkreuz, CH

Ausarbeiten der technischen Verkaufsunterlagen für das Key Account Management.Erstellen von Kalkulationen und Angebotsunterlagen sowie Rechnungserstellung für Dienstleistungen (Wartung, Hotline und...Mehr anzeigen

 • Gesponsert

Front Office Assistant

Juris Treuhand AGZug, CH

Sie suchen eine spannende Position, bei der Sie direkt mit der Geschäftsleitung arbeiten, Verantwortung übernehmen und vielseitige Einblicke gewinnen? Dann sind Sie bei uns genau richtig!.Wir sind ...Mehr anzeigen

 • Gesponsert

Junior Quant Researcher - ML Alpha Research

Squarepoint CapitalZug, Switzerland

Please only apply to the one job you feel best fits your skillset and experience.If our team feels you are better suited for another role, we will reach out about the alternate opportunity.Research...Mehr anzeigen

Sales Assistant 30% - 50% Zug

Calzedonia Switzerland AGZug, CH

Oniverse – der neue Name der Calzedonia Group – vereint einige der bekanntesten Fashion- und Lifestyle-Brands wie Calzedonia, Intimissimi, Tezenis, Falconeri und Iuman.Mit über 5’600 Stores weltwei...Mehr anzeigen

 • Gesponsert

Energy Sales Assistant

enshift AGBaar, Canton of Zug, Switzerland
Quick Apply

Bei enshift bauen wir eine führende Plattform für erneuerbare Energien im Bereich kommerzieller Grossimmobilien auf.Damit schaffen wir ein virtuelles Kraftwerk, das Photovoltaik, Stromspeicher, Wär...Mehr anzeigen

(Virtual) Assistant

BSTN Ventures GmbHZug, Canton of Zug, Switzerland
Homeoffice
Quick Apply

We're an independent strategic investment advisory and management firm.BSTN Ventures works closely with investors and entrepreneurs on a wide range of projects, including sourcing to executing of p...Mehr anzeigen

Office Manager 100%

Randstad (Schweiz) AGZug, Zug

Für unseren Kunden (Familiy Office) in Zug suchen wir einen Executive Team Assistant.Kalender- & Travelmanagement: Du koordinierst komplexe Termine über verschiedene Zeitzonen hinweg und planst Die...Mehr anzeigen

 • Gesponsert

Finance Assistant

CryptonowBaar, Zug, Switzerland
Quick Apply

Cryptonow offers digital asset services across Switzerland, Austria and the broader European market.Established in 2017, the company is dedicated to simplifying access to crypto-assets through secu...Mehr anzeigen

Wissenschaftliche*r Mitarbeiter*in Cyber Security 60 – 100%

Hochschule LuzernRotkreuz, CH

Näher dran an neuen Technologien und Talenten.Als grösste Bildungsinstitution der sechs Zentralschweizer Kantone ist die Hochschule Luzern mit ihrem Angebot am Puls der Zeit.Weitsichtig und innovat...Mehr anzeigen

 • Gesponsert

Principal - EMEA Integrated Research

IQVIAZug, Switzerland

Real World Commercial Solutions to Create a Healthier World.In RWCS we’re passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier worl...Mehr anzeigen

Personal Assistant

Marquard Family Office AGBaar, CH

Wir suchen für ein Family Office Team in Baar ZG per Mitte Juli eine.Inhaberfamilie in ihrer interessanten und abwechslungsreichen Arbeit unterstützt.Vom Büro in Baar koordinieren Sie als Persönlic...Mehr anzeigen

 • Gesponsert

Service Designer (m/w/d) 80-100 %

Sabag AGGisikon, CH

Du willst Services gestalten, die funktionieren.Mit der SABAG Service AG entsteht innerhalb der SABAG Gruppe etwas Neues.Dafür entstehen neue Teams, Funktionen und Prozesse, die Du aktiv mitgestalt...Mehr anzeigen

 • Gesponsert

System Support Engineer

ITech Consult AGRotkreuz, CH

System Support Engineer: Laboratory / Technical or Mechanical / Biosafety levels S1 and S2 / Highly regulated industry / Network Administration / Troubleshooting/ English.For our customer a big pha...Mehr anzeigen

 • Gesponsert

MECHATRONIK-INGENIEUR (M/W/D) 100%

Robatech AGMuri AG, CH

Wir sind die Grünen in unserer Branche.Eine grosse Produktevielfalt, massgeschneiderte Lösungen und Kunden aus den unterschiedlichsten Industrien und Ländern sorgen für ein anspruchsvolles und dyna...Mehr anzeigen

 • Gesponsert

Embedded Software Engineer 100%

Schiller AGBaar, CH

Embedded Software Engineer 100%.Die SCHILLER AG ist eine international führende Medtech-Unternehmung im Bereich der Herz- und Lungen-Diagnostik, Patientenüberwachung, Defibrillation, Rettungsmedizi...Mehr anzeigen

 • Gesponsert

Sales Assistant 60-80%

adidasCham, ZG, CH

Zweck & Gesamtrelevanz für die Organisation:.Trägt durch Folgendes dazu bei, die Verkaufszahlen und KPI-Ziele zu erreichen oder zu übertreffen:.Baut eine emotionale Verbindung zu den Kunden auf und...Mehr anzeigen

Team Assistant

Pala Investments Limited, St. Helier, Zweigniederlassung ZugZug, CH

Werde Teil unseres jungen und dynamischen Operations Teams! Wir suchen eine engagierte und versierte Persönlichkeit, die unser Team als Team Assistant bereichert.Organisation und Koordination von i...Mehr anzeigen

 • Gesponsert

Executive Assistant - Family Office & Structuring 60 - 80 %

CSF Management AGBaar ZG, CH

Die CSF Management AG ist ein unabhängiger Structuring Partner und arbeitet eng mit der CSF Family Office AG zusammen.Wir begleiten eine selektive Anzahl von Unternehmerfamilien mit internationalem...Mehr anzeigen

 • Gesponsert
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Lead Clinical Research Associate.

Lead Clinical Research Associate.

PSIZug, Suiza
Vor 30+ Tagen
Anstellungsart
  • Homeoffice
Stellenbeschreibung

Job Description

  • Coordinates investigator/ site feasibility and identification process, as well as study startup.
  • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
  • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
  • Manages Monitors in the query resolution process, including Central Monitoring observations.
  • Coordinates safety information flow and protocol/process deviation reporting.
  • Performs clinical supplies management with vendors on a country and regional level.
  • Ensures study-specific and corporate tracking systems are updated in a timely manner.
  • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
  • Coordinates planning of supervised monitoring visits and conducts the visits.
  • Manages the project team in site contracting and payments.
  • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
  • Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
  • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
  • Oversees project team in CAPA development and implementation.
  • Coordinates project team in process deviations review, management and reporting.
  • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
  • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
  • Delivers trainings and presentations at Investigator Meetings.
  • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
  • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
  • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
  • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
  • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
  • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
  • Ensures data integrity and compliance at a site level.
  • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
  • Conducts project-specific training of site Investigators.
  • Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

  • Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
  • Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
  • Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
  • Experience with all types of monitoring visits in Phases I-III.
  • Strong experience in Oncology preferred.
  • Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
  • Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
  • Full working proficiency in English.
  • Proficiency in MS Office applications.
  • Ability to plan, multitask and work in a dynamic team environment.
  • Excellent Communication, collaboration, and problem-solving skills.
  • Ability to travel up to 65% (depending on project needs).
  • Valid driver’s license (if applicable).

Additional Information

All your information will be kept confidential according to EEO guidelines.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.