20 beste Stellen als science research development in wien – aktuell auf Personalsuche

Local Study Associate Director
IQVIA —Wien, W
- Vollzeit
- Homeoffice
- Bachelor
Regulatory and Start Up Specialist - Austria
IQVIA —Wien, W
- Vollzeit
- Homeoffice
- Bachelor
Internship – Economic and Environmental Dimension
OSCE —Wien, W
- Vollzeit
Nuclear Programme Developer(P3)
International Atomic Energy Agency —Wien, W
- Bachelor
Insights Navigator (m/f/d)
FOUR PAWS —Wien, W
- Vollzeit
Programme Assistant(G5)
International Atomic Energy Agency —Wien, W
10 Tage
Project Associate AVRR
Iom Usrap Dc —Wien, W
- Teilzeit
- Bachelor
11 Tage
Clinical Trial Lead (m/w/d)
IQVIA —Wien, W
- Vollzeit
- Homeoffice
- Master
Visits Experience Manager
Institute of Science and Technology Austria (ISTA) —Wien, W
- Vollzeit
- Homeoffice
VC Investment Analyst (all genders)
Allocator One Group —Wien, W
- Master
- Bachelor
Direkt bewerben
University Assistant postdoctoral
Universität Wien —Wien, W
- Vollzeit
- Homeoffice
- Doktorat
Deputy Director of the CEU Library (f/m/d)
Central European University CEU —Wien, W
- Vollzeit
- Master
- Bachelor
Lead Scientist Quantitative Systems Pharmacology
Bio-LogX FlexCo —Wien, W
- Vollzeit
- Doktorat
Japanese Language Consultant
IQVIA —Wien, W
- Vollzeit
- Homeoffice
- Bachelor
2 Tage
Brand and Customer Manager Oncology (m/f/d)
MSD —Wien, W
- Vollzeit
- Homeoffice
- Bachelor
Technical Lead (Stakeholder Engagement)(P4)
International Atomic Energy Agency —Wien, W
- Master
- Bachelor
Clinical Trial Psych Rater - German Speaking
IQVIA —Wien, W
- Teilzeit
- Homeoffice
- Doktorat
- Master
Data-Driven GTM Intern (w/m/d)
Flinn —Wien, W
- Vollzeit
Direkt bewerben
Senior Scientist
Universität Wien —Wien, W
- Doktorat
Principal Biostatistician (Immunology) - FSP
IQVIA —Wien, W
- Vollzeit
- Homeoffice

Ich möchte aktuelle Job-E-Mails für Stellen als science research development in wien erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

science research development jobs near wien

Jobs als Brand Manager in Wien, W

Jobs als Investment Analyst in Wien, W

Jobs als Housekeeping Manager in Wien, W

Jobs als Brand Manager in Remote

Jobs als Brand Manager in Salzburg

Jobs als Account Executive Sales Manager Saas Ai Software in Wien

Jobs als Office Manager in Wien, W

Jobs als Brand Manager in Wien 19. Bezirk (döbling), W

Jobs als Regionalleiter, Gebietsleiter, Bezirksleiter, District Manager in Salzburg

Jobs als It Netzwerk Administrator in Sankt Pölten, NÖ

Jobs als Clinical Research Manager in Klagenfurt Am Wörthersee, K

Jobs als It System Administrator in Graz, ST

Jobs als Warehouse Assistant in Parndorf, B

Jobs als Language Assistant in Wien

Jobs als Hr Assistant in Wien

Jobs als Front Office Manager in Wien, W

Jobs als Analytics Manager in Wien

Jobs als Marketing, Online Marketing Manager, Social Media Manager, Social Media, Kommunikation in Bezirk Imst, T

Jobs als English No Experience in Graz, ST

Jobs als Investment Analyst in Wien

Local Study Associate Director

IQVIA -
Wien, W

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Bachelor

Vollständige Stellenbeschreibung

Vienna, Austria | Full time | Home-based | R1546726

To lead Local Study Teams (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director may perform site monitoring as needed to support the flexible capacity model.

The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

MAIN RESPONSIBILITIES

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Proactively identifies risks and facilitates resolution of complex study problems and issues.
Organises regular Local Study Team meetings on an agenda driven basis.
Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
Updates Line Managers about the performance of the CRAs/CSAs.
Ensures that study activities at country level comply with local policies and code of ethics.

REQUIRED SKILLS AND QUALIFICATIONS

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas.
Good knowledge of the Drug Development Process.
Excellent understanding of the Clinical Study Process including monitoring.
Very good understanding of the Study Drug Handling Process and the Data Management Process.
Excellent project management skills.
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
Excellent knowledge of spoken and written English and German language.
Good ability to learn and to adapt to work with IT systems.
Ability to travel nationally and internationally as required.

For candidates based in Austria, we offer a market-competitive gross annual salary starting at €71,400, depending on your qualifications and relevant professional experience.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

Please apply with your English CV.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

Jetzt bewerben

Erweiterte Suche

science research development Jobs in wien

Ich möchte aktuelle Job-E-Mails für Stellen als science research development in wien erhalten

Related Searches

Weitere Job-Standorte erkunden

The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

MAIN RESPONSIBILITIES

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.

Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies

Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.

Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.

Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.

Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.

Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.

Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.

Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.

Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

Proactively identifies risks and facilitates resolution of complex study problems and issues.

Organises regular Local Study Team meetings on an agenda driven basis.

Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.

Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.

Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.

Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.

Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

Updates Line Managers about the performance of the CRAs/CSAs.

Ensures that study activities at country level comply with local policies and code of ethics.

REQUIRED SKILLS AND QUALIFICATIONS

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).

Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas.

Good knowledge of the Drug Development Process.

Excellent understanding of the Clinical Study Process including monitoring.

Very good understanding of the Study Drug Handling Process and the Data Management Process.

Excellent project management skills.

Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.

Excellent knowledge of spoken and written English and German language.