Bucharest, Romania · On-site
Job 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 requiremen…
Skills: Clinical research, Site activation, Regulatory compliance, Project management, Document control
Bucharest, Romania · Hybrid
Sr CRA - Single Sponsor - Based in Bucharest Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and c…
Skills: Clinical monitoring, Site management, ICH-GCP, Regulatory compliance, Protocol compliance
Bucharest, Romania · On-site
Medical Advisor CVRM - Bucharest Diverse Minds. Bold Disruptors. Meaningful Impact. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercia…
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Bucharest, Romania · On-site
Job Description Key Account Manager Oncology GI - Cluj Diverse Minds. Bold Disruptors. Meaningful Impact. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, dev…
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Bucharest, Romania · Remote Solely
CloudLinux is a global remote-first company. We are driven by our principles: do the right thing, employees first, we are remote first, and we deliver high-volume, low-cost Linux infrastructure and security products that…
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Bucharest, Romania · On-site
We are looking for a Senior Electrical Engineer to join a Radio & Communications division and play a key role in the development of advanced communication systems. In this position, you will lead the design, development,…
Skills: DSP Firmware Development, Embedded Systems, C Programming, ARM Architecture, Modem Algorithms
Bucharest, Romania · On-site
We are looking for a Senior Engineer (FPGA) to join a Radio & Communications division and play a key role in the design, architecture, and development of advanced communication systems. This role focuses on FPGA-based mo…
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Bucharest, Romania · Hybrid
Clinical Trial Manager - Future Roles (Romania) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs an…
Skills: Clinical monitoring, Site management, ICH-GCP, Regulatory compliance, Protocol compliance
Bucharest, Romania · Remote Solely
Opportunity:- Policy Research Trainee Organization: European Institute of Policy Research and Human Rights AISBL Location: Remote Duration: 8 weeks About the Opportunity The European Institute of Policy Research and Huma…
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Bucharest, Romania · Remote Solely
We are looking to hire ambitious entrepreneurs to start and scale their own startups. We are serial entrepreneurs, for example Paul Müller (founder Adjust, €1.2B exit) and Petter Made (founder SumUp, €8B) who are eager t…
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Bucharest, Romania · On-site
Cargill is a family company committed to providing food and agricultural solutions to nourish the world in a safe, responsible, and sustainable way. We sit at the heart of the supply chain, partnering with producers and …
Skills: Food safety, Quality auditing, Root cause analysis, Quality management systems, Analytical skills
Bucharest, Romania · Hybrid
$192k–$309k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Medical affairs, Immunology, Stakeholder management, Scientific communication, Clinical research
Bucharest, Romania · Remote OK
Experienced Clinical Research Associate - Sponsor Dedicated IQVIA Romania is looking for talented and motivated team member to join our Sponsor dedicated team as Senior CRA. At this position you will have the opportunity…
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Bucharest, Romania · On-site
Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor r…
Skills: Clinical Research, Site Monitoring, Good Clinical Practice, ICH Guidelines, Regulatory Compliance
Bucharest, Romania · Remote OK
$162k–$260k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Immunology, Pharmaceutical sales, Business development, Relationship building, Strategic sales planning
Bucharest, Romania · On-site
RESPONSABILITĂŢI SPECIFICE Asigură o informare corectă și completă a profesioniștilor în domeniul sănătății în legătură cu portofoliul de produse pe care le promovează. Depune toate diligențele în conformitate cu atribuț…
Skills: Medical promotion, Pharmaceutical industry knowledge, Communication, Public speaking, Presentation skills
Bucharest, Romania · On-site
Position Summary The Medical Safety Director, Clinical Scientist provides clinical science support to product activities, ensuring high-quality clinical input into routine maintenance documentation, safety and labeling d…
Skills: Clinical Science, Pharmacovigilance, Drug Safety, Risk Management, Regulatory Compliance
Bucharest, Romania · Hybrid
$14k–$18k/mo
Join the Market Leader in Electric Power Data and Analytics Solutions The electrical grid is the largest and most complicated machine ever built. Yes Energy’s industry-leading electric power trading analytics software pr…
Skills: Python, SQL, Predictive modeling, Forecasting, Machine learning
Bucharest, Romania · Remote Solely
Would you like to build the backend behind maritime geospatial analytics, from wherever you already live? This role sits with an international scientific and technology centre working on maritime research. The work is re…
Skills: Python, FastAPI, Neo4j, Databricks, Domain Driven Design
Bucharest, Romania · Hybrid
Company Renault Techno Roumanie Job Description 🚀 Internship-ul face parte din echipa DIR RTR FBI-S / Innovation, Renault Techonologie Roumanie. Bine ai venit în viitor… în Drive Your Future, programul nostru de interns…
Skills: 3D Modeling, 3D Printing, Fusion 360, SolidWorks, Additive manufacturing
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The Regulatory and Start Up Specialist manages site activation activities and serves as the primary point of contact for investigative sites and project teams. They ensure all regulatory documents are accurate, compliant with SOPs, and tracked according to project timelines.
Candidates must have at least 2 years of clinical research experience and possess fluency in Romanian. Proficiency in managing regulatory documentation and site activation processes is essential for this role.
Job 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.
Require Romanian fluency.
Essential Functions
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.
Qualifications
At least 2 years' clinical research experience.
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.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US
There are currently 180 open science & research positions in Bucharest, Romania listed on Clera. New openings are added daily as companies post roles.
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