![IQVIA](https://media.trabajo.org/img/noimg.jpg)
Regulatory & Study Start-up Specialist (M/w/d)
vor 2 Monaten
We currently offer an exciting opportunity as **Regulatory & Start-Up Specialist (m/w/d)** to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well.
**While projects vary, your typical responsibilities might include**:
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Review, prepare and negotiate site contracts and budgets with sites.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Distribute completed documents to sites and internal project team members.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
- Perform quality control of documents provided by sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
**You should have**:
- Bachelor's Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience
- Fluent languages skills in German on at least C1 level and good command of English
- Effective communication, organizational and planning skills
- Ability to work independently and to effectively prioritize tasks
- Ability to work on multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
We invite you to join IQVIA.
-
Regulatory & Study Start-up Specialist (M/w/d)
vor 1 Woche
Wien, Wien, Österreich IQVIA VollzeitWe currently offer an exciting opportunity as Regulatory & Start-Up Specialist (m/w/d) to work in both fields of _ethics and submissions_ and _contracting and budget negotiations_ in our Country Site Activation Department. You can work in our Vienna office, alternatively you can work home-based as well.While projects vary, your typical responsibilities might...
-
Study Start Up Manager
vor 2 Wochen
Wien, Österreich Novartis VollzeitThe SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO...
-
Study Start-up Manager
vor 1 Woche
Wien, Wien, Österreich AstraZeneca Vollzeit**Study Start-up Manager (M/F/d) - Schwerpunkt Studienverträge****Standort: Wien/Remote**AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung undVermarktung verschreibungspflichtiger Arzneimittelkonzentriert. Weltweit profitieren Millionen Patient:innen von unseren innovativen...
-
Project Manager Study-start-up
vor 1 Woche
Wien, Wien, Österreich Fortrea VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Specialist or Senior Specialist
vor 2 Wochen
Wien, Österreich Novasyte VollzeitIQVIA currently offers the exciting opportunity as experienced Study Start-Up Specialist / Site Activation Specialist (m/w/d) to work in the Country Site Activation Department in our Vienna office or in home office throughout Austria. In this role you will perform tasks at a country level associated with clinical research site activation activities in...
-
Project Manager Study-Start-Up
vor 1 Woche
Wien, Wien, Österreich Pharmiweb VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Site Start Up Specialist
vor 1 Woche
Wien, Wien, Österreich Thermo Fisher Scientific VollzeitOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...
-
Project Manager Study-start-up
vor 1 Woche
Wien, Österreich Fortrea VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Job Posting Title Regulatory and Start Up
vor 2 Wochen
Wien, Österreich Novasyte VollzeitRegulatory and Start Up Specialist IQVIA RSU Work from any location Must speak German and English Join us on our exciting journey! IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers. We set ourselves apart with...
-
Fsp Regulatory
vor 1 Woche
Wien, Österreich Novasyte VollzeitJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...
-
Regulatory and Start Up Specialist
vor 1 Woche
Wien, Österreich Novasyte VollzeitJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. _Must be a German fluent with German...
-
Project Manager Study-Start-Up
vor 1 Woche
Wien, Wien, Österreich AUS Fortrea Austria GmbH VollzeitFortrea: Leading CRO in Clinical DevelopmentFortrea is a top global Contract Research Organization (CRO) dedicated to scientific excellence and extensive experience in clinical development. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers a wide array of solutions across 20+ therapeutic areas. With a vast team of over 19,000...
-
Site Start Up Specialist
vor 2 Wochen
Wien, Österreich Thermo Fisher Scientific VollzeitOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Study Start-up Manager
vor 2 Wochen
Wien, Österreich AstraZeneca Vollzeit**Study Start-up Manager (M/F/d) - Schwerpunkt Studienverträge** **Standort: Wien/Remote** AstraZeneca ist eines der weltweit führenden biopharmazeutischen Unternehmen, welches sich auf die Entdeckung, Entwicklung undVermarktung verschreibungspflichtiger Arzneimittelkonzentriert. Weltweit profitieren Millionen Patient:innen von unseren innovativen...
-
Regulatory and Start Up Specialist
vor 1 Woche
Wien, Wien, Österreich Novasyte VollzeitJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. _Must be a German fluent with German experience._Essential...
-
Associate Start-up Incubator
vor 1 Woche
Wien, Wien, Österreich Karriere - Jobportal VollzeitMit einer Community von rund 900 Forscherinnen, Unternehmerinnen, Start-Uppern und Studierenden inmitten der Südtiroler Alpen begleitet unser Kunde unternehmerische Ideen in die Zukunft.Du willst Entwicklung aktiv mitgestalten und Netzwerke knüpfen? Dann bewirb dich und werde Associate Start-Up Incubator (m/w/d).Aufgaben- Betreuung von bereits inkubierten...
-
Start-up Entrepreneur
vor 1 Woche
Wien, Wien, Österreich Möbel Ludwig VollzeitMöbel Ludwig ist eine Marke der K. Ludwig Gesellschaft m.b.H., einem österreichischen Familienunternehmen, das im In- und Ausland auf verschiedenen Märkten aktiv ist. Zur Umsetzung eines neuen Vertriebskonzeptes im Online Handel suchen wir einen durchsetzungsstarken und leistungsorientierten**Start-Up Entrepreneur (m/w/d)**:**Ihre Aufgaben**:- Entwicklung...
-
Start-up Entrepreneur
vor 1 Woche
Wien, Wien, Österreich K. Ludwig Ges.m.b.H. VollzeitMöbel Ludwig ist eine Marke der K. Ludwig Gesellschaft m.b.H., einem österreichischen Familienunternehmen, das im In- und Ausland auf verschiedenen Märkten aktiv ist. Zur Umsetzung eines neuen Vertriebskonzeptes im Online Handel suchen wir einen durchsetzungsstarken und leistungsorientiertenStart-Up Entrepreneur (m/w/d)Das erwarten wir von...
-
Start-up Entrepreneur
vor 3 Wochen
Wien, Österreich Möbel Ludwig VollzeitMöbel Ludwig ist eine Marke der K. Ludwig Gesellschaft m.b.H., einem österreichischen Familienunternehmen, das im In - und Ausland auf verschiedenen Märkten aktiv ist. Zur Umsetzung eines neuen Vertriebskonzeptes im Online Handel suchen wir einen durchsetzungsstarken und leistungsorientierten **Start-Up Entrepreneur (m/w/d)**: **Ihre Aufgaben**: -...
-
Regulatory Affairs Specialist
vor 1 Woche
Wien, Wien, Österreich AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit VollzeitZur Unterstützung im Institut Zulassung & Life Cycle Management suchen wir eine/nRegulatory Affairs Specialist (w/m/d) - Case Manager**Ihre Aufgaben**:- Bearbeitung von Anfragen zu RMS Verfahren, Durchführung von Presubmission Meetings, Beratung von Antragstellern (Regulatory Advice)- Fachliche Validierung der eingereichten Dossiers (Zulassungs-, und...