Dalian, Liaoning, China · On-site
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 contra…
Skills: Site Activation, Clinical Research, Regulatory Documentation, GCP/ICH Guidelines, Project Planning
Beijing, Beijing, China · On-site
Job Overview Provides administrative and/or technical support. Recruitment Process 第一轮：线上测评 完成指定的线上测试，用于初步筛选。 第二轮：业务面试 与业务部门进行面谈，深入了解您的专业背景与职位匹配度。 第三轮：结果通知 招聘团队将在流程结束后，正式告知最终结果。 Essential Functions • Responsible to recon…
Skills: SAP, Financial Reconciliation, Journal Entries, Data Analysis, SharePoint
Bengaluru, Karnataka, India · On-site
Shift Time: 5:30AM onwards Location: Bangalore, office-based Customer service, voice training. BPO - voice process Experience Required: Minimum 6 months Domain Exposure: any domain Mandatory Skills: Good communication an…
Skills: Customer Service, Voice Process, Communication Skills, Presentation Skills
New Cairo City, Cairo, Egypt · On-site
Job Overview Provide high level technical and general accounting services in accordance with IQVIA Finance Standard Operating Procedures (SOPs), US Generally Accepted Accounting Principles (US GAAP), Sarbanes-Oxley rules…
Skills: General Ledger Reconciliation, Journal Entries, Financial Reporting, US GAAP, Sarbanes-Oxley Compliance
Zaventem, Flanders, Belgium · Hybrid
Ervaring als medisch afgevaardigde op zak en zin om verder te bouwen? In deze rol krijg je autonomie en de kans om je talenten volop te ontwikkelen in het veld. Wat houdt de job in? Promotie van het Sandoz‑portfolio bij …
Skills: Sales, Account Management, Negotiation, Analytical Insight, CRM Systems
Milan, Lombardy, Italy · Hybrid
$40k–$60k/yr
Overview IQVIA is looking for a Regulatory Affairs Consultant to join our Regulatory Affairs & Pharmacovigilance team in Italy. This role will support a range of client projects focused on the lifecycle management of med…
Skills: Regulatory Affairs, Lifecycle Management, Post-Approval Changes, Marketing Authorizations, Promotional Material Review
Zaventem, Flanders, Belgium · On-site
Combineer je medische kennis en communicatieve skills als jr. medisch afgevaardigde en bouw sterke vertrouwensrelaties op met artsen in regio Antwerpen, Edegem, Wilrijk, Mortsel, Putte, Lier Wat houdt de job in? Klanteno…
Skills: Customer Relationship Management, Scientific Communication, Sales Driven, Strategic Planning, Market Analysis
Bloemfontein, Free State, South Africa · Remote Solely
IQVIA is growing! Hiring multiple Clinical Data Management (CDM) Leads across our FSP (Functional Service Provider) and Traditional (Sponsor-Agnostic) delivery models. Apply now and have your resume considered for Lead D…
Skills: Clinical Data Management, Study Setup, Database Lock, Client Management, Resource Allocation
Thane, Maharashtra, India · On-site
Job Location: Calicut Job Overview Maximize sales growth in a specified geographical territory, consistent with Company strategy and objectives. This is generally achieved by educating and informing physicians and/or hos…
Skills: Sales Growth, Physician Education, Territory Management, CRM Systems, Pre-call Planning
Gurugram, Haryana, India · On-site
IQVIA™ is The Human Data Science Company™, combining data, technology, advanced analytics, and human expertise to help healthcare clients improve outcomes for patients. Our solutions support better decision-making across…
Skills: Quantitative Analysis, Qualitative Analysis, Primary Research, Secondary Research, Strategy Consulting
Warsaw, Masovian Voivodeship, Poland · Remote Solely
$103k–$273k/yr
Responsibilities • Ensure consistent processes and efficient review of critical clinical/safety data • Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding …
Skills: Pharmacovigilance, Drug Safety, Clinical Data Review, ICH/GCP Guidelines, SAE Reporting
São Paulo, São Paulo, Brazil · Hybrid
Sobre a IQVIA: A IQVIA é líder global em Human Data Science, oferecendo soluções integradas de pesquisa clínica, informação e tecnologia para o setor de saúde. Combinando dados, expertise analítica e inovação, apoiamos n…
Skills: Customer Service, Client Relationship Management, Data Analysis, Microsoft Excel, Microsoft PowerPoint
New Delhi, Delhi, India · On-site
Job Overview Provides high quality, timely development and on-time input to solutions for service delivery, managed services, or implementation oriented client projects. Assignments range in complexity from basic analysi…
Skills: Market Research, Product Development, Stakeholder Management, Business Analysis, Consulting Methodologies
São Paulo, São Paulo, Brazil · On-site
Estamos em busca de um(a) profissional júnior para atuar na área de Produção OKAI, com foco em contato com painéis e coleta de dados. Essa posição é ideal para quem gosta de rotina estruturada, comunicação e organização.…
Skills: Active Contact, Data Collection, Follow-up, Customer Service, Organization
New Cairo City, Cairo, Egypt · On-site
Job Purpose The Regional Key Account Manager (SPOT Manager) plays a critical role in driving sustainable business growth, strategic customer development, and commercial excellence across the animal health market within t…
Skills: Strategic Planning, Key Account Management, Distributor Management, Sales Performance Management, Team Leadership
Tokyo, Japan · On-site
所属部署・チーム名 Japan RBU 契約管理部 ※法人上の所属は「ソリューションズ（契約管理部）」となります。 部署概要 本部門は、ソリューションズおよびサービシーズのCSMSに関連する顧客契約およびベンダー契約を担当しています。両法人にまたがる契約書対応を行う専門チームであり、Japanローカル組織としてプレジデント直轄の位置づけにあります。 主要なステークホルダーは、営業部門、プロジェクトマネージャー、法務、財務、人事など多岐に…
Skills: Contract Drafting, Contract Review, Corporate Legal Affairs, Stakeholder Management, Japanese Language Proficiency
Milan, Lombardy, Italy · On-site
$48k–$71k/yr
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and …
Skills: GCP Auditing, Clinical Trial Audits, CAPA Management, Root Cause Analysis, Regulatory Compliance
Remote Solely
JOB OVERVIEW Do you have a keen eye for detail and a passion for ensuring the accuracy and clarity of medical documents? We’re on the hunt for skilled Freelance regulatory affairs translators (English into Icelandic) to …
Skills: English to Icelandic Translation, Regulatory Affairs Translation, Medical Translation, Post-editing, CAT Tools
Seoul, South Korea · On-site
아이큐비아는 제약·바이오 및 헬스케어 분야에서 압도적인 데이터 전문성을 기반으로 독보적인 입지를 구축한 글로벌 프로페셔널 서비스 기업입니다. 그 중 전략 컨설팅 부서는 국내·글로벌 제약사 및 바이오-테크, PE·VC, 헬스케어 사업을 영위하는 대기업 등을 대상으로 다양한 전략 프로젝트를 수행하고 있습니다. Essential Functions • Conducted strategic consul…
Skills: Strategic Consulting, Market Analysis, Forecasting, Due Diligence, Asset Valuation
Ho Chi Minh City, Vietnam · On-site
Job overview: Responsible for quality and service to client, assisting client obtains maximum value from IQVIA information products and services. General functions Own the end-to-end quality and timely delivery of client…
Skills: Technical Skills, Analytical Skills, Power Bi, Sql, Business Acumen
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The role serves as the Single Point of Contact for site activation activities, ensuring adherence to SOPs and project timelines. Responsibilities include preparing regulatory documents, tracking approvals, and maintaining internal project databases.
Requires a Bachelor's degree in life sciences or a related field with at least 3 years of clinical research experience, including 1 year in a leadership capacity. Candidates must have in-depth knowledge of GCP/ICH guidelines and the drug development process.
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 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
• Bachelor's Degree 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.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• 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.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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
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
