Sofia, Sofia-City, Bulgaria · On-site
Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope o…
Skills: Site activation, Regulatory affairs, Clinical trials, Project management, Budget planning
Fairfax, Virginia, United States · On-site
$62k–$156k/yr
Job Summary The Infusion Nurse must be knowledgeable of standard oncology care practices. The Infusion Nurse advocates for patient safety and protocol integrity, adheres to nursing standards, and communicates effectively…
Skills: Oncology Care, Venipuncture, Central Venous Access Device Management, Chemotherapy Administration, Biotherapy Administration
Netanya, Center District, Israel · On-site
Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functi…
Skills: Clinical research, Trial master file, Administrative support, Regulatory compliance, Clinical documentation
Bengaluru, Karnataka, India · On-site
IQVIA is seeking a Consultant to support Consumer Health Analytics engagements across BE and broader European markets. The role requires a strong blend of commercial analytics expertise, client-oriented problem solving, …
Skills: Commercial analytics, Data interpretation, Market research, Strategic decision-making, Storytelling
Sofia, Sofia-City, Bulgaria · Remote OK
IQVIA Medical Communications (IMC) is seeking an Account Manager with client handling, financial management, and project delivery expertise. The ideal candidate will have experience leading assigned programs and projects…
Skills: Client handling, Financial management, Project delivery, Budgeting, Cross-functional team coordination
Buenos Aires, Argentina · Remote Solely
Internal Job Description We are seeking experienced laboratory professionals to join the Project Services team at IQVIA Laboratories. This role is 100% remote (Eastern Time business hours). We are hiring at multiple leve…
Skills: Clinical trial management, Project management, Laboratory operations, Risk management, Stakeholder management
Ciudad de México, Mexico · On-site
We are seeking a strategic and results-driven Senior Recruiter to manage end-to-end recruitment processes across Latin America. This professional will serve as a trusted business partner to hiring managers, driving talen…
Skills: Full-cycle recruiting, Talent acquisition, Sourcing strategies, Stakeholder management, Candidate experience
Parsippany, New Jersey, United States · Remote OK
$95k–$105k/yr
As a global leader in commercial solutions, IQVIA is uniquely positioned to deliver results both nationally and internationally. Our teams partner with biopharma companies to bring essential medicines to the people who n…
Skills: Patient education, Chronic disease management, Treatment adherence, Clinical pharmacology, Presentation skills
Warsaw, Masovian Voivodeship, Poland · On-site
$105k–$194k/yr
Junior Medical Science Liaison - Future Opportunity (Talent Pipeline) Location: Poland About the Opportunity We are building a pipeline of talented professionals for anticipated Junior Medical Science Liaison (MSL) roles…
Skills: Scientific Communication, Clinical Data Interpretation, Medical Affairs, Presentation Skills, Relationship Building
Beijing, Beijing, China · On-site
Essential Functions QC of project database(s) and requisition forms versus the sponsor protocol and sponsor specific requirements.Cross functional collaboration to ensure QC reviews reflect current process and quality st…
Skills: Quality Control, Project Management, Clinical Research, Data Analysis, Process Improvement
Mississauga, Ontario, Canada · On-site
$98k–$148k/yr
IQVIA est le leader mondial de la fourniture de données sanitaires et pharmaceutiques au secteur des soins de santé. Notre équipe de services de conseil et d’analyse est réputée pour offrir à ses clients une perspective …
Skills: Analytical modeling, Quantitative analysis, Qualitative analysis, Project management, Data visualization
Mississauga, Ontario, Canada · On-site
$73k–$121k/yr
IQVIA est le leader mondial de la fourniture de données sanitaires et pharmaceutiques au secteur des soins de santé. Notre équipe de services de conseil et d’analyse est réputée pour offrir à ses clients une perspective …
Skills: Data analysis, Quantitative analysis, Qualitative analysis, Consulting methodologies, Life sciences
Durham, North Carolina, United States · Remote OK
$51k–$127k/yr
IQVIA is looking for a Clinical Project Coordinator to join our growing team. Role can be homebased anywhere in the US. Support, with minimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with p…
Skills: Project management, Clinical trials, GCP, ICH guidelines, Regulatory compliance
Shanghai, Shanghai, China · On-site
Provide project related assistance for assigned project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in a…
Skills: Clinical research, Regulatory requirements, ICH GCP, Project management, Communication
Durham, North Carolina, United States · On-site
$93k–$233k/yr
We are seeking a Senior Global Trial Manager to join our team! We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purp…
Skills: Clinical trial management, Project management, Regulatory compliance, GCP, ICH guidelines
Seoul, South Korea · On-site
As part of IQVIA’s industry-leading global Real-World Evidence (RWE) solutions, the Health Technology Assessment & Health Economics (HTA/HE) team is a young, dynamic, and fast-growing group of Master’s- and PhD-level res…
Skills: Economic Modelling, Observational Studies, Systematic Reviews, Meta-analysis, Value Communication
Carlsbad, California, United States · On-site
The Part Time Clinical Consultant (PTCC) role is an exciting opportunity to join IQVIA. IQVIA/MedTech takes the approach to helping customers drive healthcare forward in this challenging, fast-paced environment. We help …
Skills: Clinical consulting, Ventricular medical device support, Patient management, Cardiac ICU, Cardiovascular ICU
Dalian, Liaoning, China · On-site
Job Overview Acts as a Lead Medical Writer on straightforward projects (e.g. simpler documents under standard timelines). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and cust…
Skills: Medical writing, Regulatory knowledge, GCP, Drug development, Project management
Kansas City, Missouri, United States · On-site
$70k–$77k/yr
Portfolio Sales Specialist – Surgery Products Location: Field-based / Territory-based IQVIA is seeking a motivated and consultative Portfolio Sales Specialist to support growth across a designated portfolio of surgery pr…
Skills: Sales, Consultative selling, Account planning, Business acumen, Negotiation
Zaventem, Flanders, Belgium · On-site
Voor een opportuniteit bij één van onze klanten zoekt IQVIA een medisch afgevaardigde. Je komt terecht bij een jong en dynamisch bedrijf met een uitstekende reputatie en een sterke groei. De organisatie is marktleider bi…
Skills: Sales, Relationship building, Strategic thinking, Communication, Proactivity
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Manage the delivery of site activation, maintenance, and regulatory activities for clinical studies while overseeing project budgets and resources. Provide regulatory strategy and technical support to ensure compliance and facilitate efficient study initiation.
Requires a Bachelor's degree in Life Sciences and at least 7 years of relevant experience in a scientific or clinical environment. Candidates must possess strong knowledge of GCP/ICH guidelines and proven ability to manage complex, multi-regional clinical projects.
Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
Bachelor's Degree Life sciences or related field Req
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role
Strong negotiation and communication skills with ability to challenge
Excellent interpersonal skills and strong team player
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
Demonstrated proficiency in using systems and technology to achieve work objectives
Good regulatory and/or technical writing skills
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
Good leadership skills, with ability to motivate, coach and mentor
Good organizational and planning skills
Ability to exercise independent judgment taking calculated risks when making decisions
Good presentation skills
Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Excellent understanding of study financial management
Proven ability to work on multiple projects balancing competing priorities
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
