- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
-
Regulatory and Start Up Specialist 2
3 dni temu
IQVIA Warsaw, Polska W pełnym wymiarze godzinJob 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 ...
-
Clinical Start-Up Specialist, CDC PL
1 tydzień temu
Novo Nordisk A/S Warsaw, PolskaAre you a proficient relationship manager with a knack for maintaining professional connections? Do you have a keen eye for detail? If you are poised to enact positive change within our clinical department, you could be the ideal candidate for the role of Clinical Start Up Specia ...
-
Study Start Up and Regulatory Affairs Specialist
1 tydzień temu
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review ...
-
Study Start Up and Regulatory Affairs Specialist
1 tydzień temu
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and revi ...
-
Aws And Hpc Specialist
1 tydzień temu
Itfs Sp. Z O.o. Warsaw, Polska W pełnym wymiarze godzinAWS and HPC Specialist Miejsce pracy: Warszawa Technologie, których używamy Wymagane AWS HPC EFA O projekcie Workplace: 100% remote Start: ASAP Form of cooperation: B2 B with ITFS, full-time and long-term cooperation Rate: PLN/h net + VAT We are seeking a highly skilled and exper ...
-
PR / Influencer Specialist
4 dni temu
Next Technology Professionals Warsaw, Polska· Dla naszego klienta poszukujemy kandydatów na stanowisko: · PR Specialist · Projekt: Poszukujemy PR Specialist, który będzie odpowiedzialny za stworzenie i wdrażanie strategii PR dla gry, która jest połączeniem Football Managera i Frostpunka. Gra będzie dystrybuowana na rynku ...
-
Application Developer
1 tydzień temu
ITFS sp. z o.o. Warszawa, PolskaExpected, Python, Pandas, DaskAbout the project, Location: 100% remote, Start: ASAP, Form of cooperation: B2B with ITFS, Salary: zł/h netto + VAT, Project duration: Until 28th of June 2024 (possible extension), Project: An Intelligent Supply Chain Platform.Your responsibilities, ...
-
Business Analyst
6 dni temu
ITFS sp. z o.o. Warszawa, PolskaExpected, SAP SD, SAP EDIAbout the project, Location: remote work, Start: ASAP, Type of contract: B2B with ITFS, Salary: pln/h netto + VAT (depends on experience), Client: consultingYour responsibilities, Application maintenance role: tackling incidents and RFCs in SAP SD area (+ ...
-
Performance Tester
2 dni temu
ITFS sp. z o.o. Warszawa, PolskaExpected, Performance Testing, JmeterAbout the project, Workplace: hybrid (1 day per week from client's office located in one of cities in Poland: Lodz / Warsaw / Gdansk), Start: ASAP (2 weeks notice period is a max.), Form of cooperation: B2B with ITFS (first contract for 6 mont ...
-
Java Developer
1 tydzień temu
ITFS sp. z o.o. Warszawa, PolskaExpected, Java, Spring Framework, Hibernate, Maven, SQL, AWSAbout the project, Location: Hybrid work (1 day x 2 weeks work from Warsaw office), Start: ASAP (max 1 month), Form of cooperation: B2B with ITFS, Salary: zł/h netto + VAT, Project: longtermYour responsibilities, Support ...
-
SAP Fiori Frontend Developer
1 dzień temu
ITFS sp. z o.o. Warszawa, PolskaExpected, UI5, Fiori, JavaScript, HTML5, CSS3, oData, WebIDE, CDS ViewAbout the project, Location: 100% remote, Start: ASAP (max 1 month), Form of cooperation: B2B with ITFS, Salary: zł/h netto + VAT, Project: till the end of the year (possibility of extension)Your responsibiliti ...
-
Salesforce Marketing Cloud Developer
1 tydzień temu
ITFS sp. z o.o. Warszawa, PolskaExpected, Salesforce Marketing Cloud, Data Cloud, AWS, Azure SQL, Google Cloud Platform, JavaScriptAbout the project, Workplace: 100% remote, Start: ASAP (max. 30 days notice period), Form of cooperation: B2B with ITFS (12 months with the possiblity to prolong), Rate: PLN/h net + ...
-
Technology & Innovation Campaign Manager
1 tydzień temu
ITFS sp. z o.o. Warszawa, PolskaExpected, Project management, Digital StrategyAbout the project, Location: hybrid work (Warsaw), Start: ASAP (max. 1 month notice period), Type of contract: B2B with ITFS, Salary: 70 – 100 zł/h netto + VAT, Client: consultingYour responsibilities, Collaborate with the cross-funct ...
-
SAP Administrator
1 tydzień temu
ALTER SOLUTIONS Warsaw, Polska W pełnym wymiarze godzinOpis firmy · Naszą misją jako firmy świadczącej usługi w obszarze IT jest dostarczanie naszym Klientom na całym świecie najlepszych rozwiązań. Udaje się to nam dzięki analizie potrzeb Klientów oraz dopasowaniu ich do umiejętności i aspiracji naszych pracowników. Dlatego jedną z ...
-
Senior Salesforce Developer @
1 tydzień temu
1dea Warsaw, Polska W pełnym wymiarze godzinFor one of our key Clients we're looking for a specialist for the position of: Senior Salesforce Developer Terms of engagement: Area: Media / Entertainment Localisation: 100% remote Start: ASAP (max 3 month notice period) Salary rate (determined individually): PLN net + VAT / h T ...
-
Junior Sales Specialist With German
1 dzień temu
Teleperformance Poland Warsaw, Polska W pełnym wymiarze godzinTeleperfomance is recruiting for Veeam - #1 Global Leader in Data Protection and Ransomware Recovery ) We are looking for a Junior Sales Specialists for sales department IT area: data protection, data recovery, clouds - does it ring a bell? Even if it sounds like a rocket science ...
-
Collections Specialist
1 tydzień temu
IWG plc Warsaw, Polska W pełnym wymiarze godzinCollections Specialist · This job is for you if you have the following; · *Excellent communication skills. · *Determination and resilience. · *Previous experience in a credit control or phone-based customer service job. · We offer hybrid work, a competitive salary and commission ...
-
Senior Data Governance Consultant @
1 tydzień temu
1dea Warsaw, Polska W pełnym wymiarze godzinFor one of our key Clients we're looking for an expert specialist for the position of: Senior Data Governance Consultant Terms of engagement: Area: Consulting IT (project for the EU Public Area) Localization: 100% remote. · Start: ASAP (max 1 month notice period) Salary rate (det ...
-
Senior Sap Abap Consultant
1 tydzień temu
1dea Warsaw, Polska W pełnym wymiarze godzinFor one of our key Clients we're looking for an expert specialist for the position of: Senior SAP ABAP Consultant (+ SAP Workflow) Terms of engagement: Area: Consulting IT Localisation: 100% remote. · Start: ASAP (max 3 months notice period) Salary rate (determined individually): ...
-
Aws And Hpc Specialist
4 dni temu
Itfs Sp. Z O.o. Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : AWS HPC EFA about-project : Workplace: 100% remote Start: ASAP Form of cooperation: B2 B with ITFS, full-time and long-term cooperation Rate: PLN/h net + VAT We are seeking a highly skilled and experienced AWS and HPC Specialist with expertise in Elastic F ...
Regulatory and Start Up Specialist 1 - Warsaw, Polska - IQVIA
Opis
ob 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. At least 1 years' experience with submissions and CTIS experience. Fluent in Polish and English.
Essential Functions
Qualifications
1-year clinical research experience. Equivalent combination of education, training and experience.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at