Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
Athens, Attica, Greece · On-site
Senior+$4.6B raised
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcar…
Skills: COA Endpoint Strategy, Regulatory Strategy, COA Instrument Development, Patient-Reported Outcomes, FDA Engagement
Hong Kong, Hong Kong Island, Hong Kong S.A.R. · On-site
Mid level$4.6B raised
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…
Our RN Clinical Educators experience a unique opportunity to employ their clinical nursing expertise in a new way outside patient care, while continuing to collaborate with healthcare professionals and advocate for the w…
Freelance Medical Post-Editors Italian into English
Remote Solely
Mid level$4.6B raised
Exciting Opportunity for Freelance Medical Post-Editors Italian into English! 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 Free…
Exciting Opportunity for Freelance Medical Post-Editors (French-English)! 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 Freelanc…
Skills: Medical translation, Post-editing, Clinical trial documentation, Medical terminology, Attention to detail
Responsibilities Manage learner assignments on our OnPoint platform based LMS across assigned customers. This includes management of resources, systems, and processes (SOPs/work instructions): Create and deploy of traini…
Skills: LMS Management, Project Management, Training Delivery, E-learning Creation, Data Reporting
As the only global provider of commercial solutions, IQVIA understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers …
Skills: Sales, Business acumen, Analytical skills, Persuasion, Influence
Gestionnaire principal des données, Lead Data Manager
Kirkland, Quebec, Canada · On-site
$108k–$144k/yr
Senior$4.6B raised
Au moins 7 ans d'expérience en gestion de données cliniques dans les secteurs pharmaceutique, biotechnologique ou au sein d'une CRO. Solide connaissance des processus d'essais cliniques, de leur lancement à leur clôture.…
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, GCP, ICH guidelines, Subject recruitment
Patient interview moderator IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that h…
Skills: Qualitative research, Patient interviewing, Active listening, Clinical terminology, Data analysis
(Associate) Consultant, Primary Market Research (Healthcare)
Seoul, South Korea · On-site
Mid level$4.6B raised
Job Overview • Provide high quality, on-time input to market research projects in the healthcare field, with limited support/guidance from senior member/project leader. • Assignments range in complexity from basic analys…
Data Acquisition Specialist - External Data (Remote - UK)
London, England, United Kingdom · Remote OK
Mid level$4.6B raised
The Data Acquisition Specialist performs activities relating to the definition, set-up and ingestion of External Data Streams, and related documents and processes aligned with Clinical Trial Protocol defined requirements…
Skills: Clinical Research, Data Acquisition, Data Management, Data Transfer Agreements, Clinical Trials
Job Overview Direct and manage the execution of the strategic, operational and financial delivery of required Site Activation activities, including but not limited to Site ID and Selection, Ethics and Regulatory processe…
Associate Medical Director, Cardiology , with Metabolic Diseases and Nephrology Experience
Rome, Lazio, Italy · On-site
$74k–$126k/yr
Senior$4.6B raised
Job Overview The Associate Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned tria…
Skills: Medical Monitoring, Clinical Trial Management, Cardiology, Metabolic Diseases, Nephrology
Bogota, Capital District, RAP (Especial) Central, Colombia · On-site
Mid level$4.6B raised
¡Únete a nosotros en nuestro emocionante trayecto! IQVIA ™ es The Human Data Science Company ™, enfocada en el uso de datos y ciencia para ayudar a los clientes de la salud a encontrar mejores soluciones para sus pacient…
Skills: Medical sales, Medical devices, Urology, Surgery, General medicine
Minimum 7+ years of Clinical Data Management experience in pharmaceutical, biotechnology, or CRO environments. Strong knowledge of clinical trial processes from study start-up through closeout. Experience leading Data Ma…
IQVIA Hungary is looking to hire an Intern to support our clinical activities. Position is full time, with 6 months fix term contract, office based in Budapest. The program is designed to educate Interns on Clinical Tria…
Skills: Clinical Trials, Clinical Research, Site Management, Clinical Research Associate, Clinical Site Activation
Job Overview Responsible for performing routine analysis and laboratory testing procedures. Essential Functions • Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory gu…
Skills: Analytical procedures, Laboratory testing, Data analysis, SOP compliance, LIMS
Job Overview Directs financial planning and accounting practices including: budgeting, costing, financial analysis, and long-range forecasting for a mid-sized market or regional function(s). Partners with the business, p…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
postgraduate degree
Posted 8d ago
~40 hrs/week
Responsibilities
Serve as a subject matter expert in Clinical Outcome Assessment (COA) strategy, leading endpoint development and regulatory interactions for pharmaceutical clients. Oversee the creation of scientifically robust COA instruments and provide internal quality assurance and mentorship to project teams.
Requirements
Requires deep expertise in COA types and extensive experience developing endpoint strategies and instruments for regulatory submission. An advanced degree (PhD, MD, PharmD, DrPH, or MSc) in a relevant scientific discipline is strongly preferred.
Full job description
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
The Patient Centered Solutions team(PCS)
The PCS team leads the industry in the science of measuring the patient experience. We pair strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research that incorporates the patient voice into the development and commercialization of new medicines. This research includes qualitative (e.g., patient interviews, focus groups), quantitative (e.g., clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and physician experiences and expectations of disease and treatment.
Why join?
Become part of a recognized global leader in patient-focused research
Keep growing with an organization that encourages and invests in continuous professional and personal development
Apply your business and leadership skills in an entrepreneurial and multi-disciplinary team
Continue challenging yourself by addressing the toughest client issues, working across multiple geographies and solutions in a dynamic and crucial field for the industry
Make a difference to patients by enabling the successful approval or launch of new treatments with features that are truly patient-centric
Responsibilities
The Associate Principal/ Principal Clinical Outcome Assessment (COA) Endpoint Strategy serves as the subject matter expert for COA endpoint strategy, endpoint development, COA regulatory strategy, and COA instrument science in client engagement and project delivery. This role brings deep expertise in COA measurement science to differentiate client solutions through expert-driven, highly insightful endpoint strategies. The role acts as a trusted advisor to pharmaceutical and biotechnology sponsors and represents IQVIA as an external scientific thought leader while ensuring internal scientific quality and best practices. Key responsibilities include:
Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects.
Bring COA expertise into client meetings, workshops, and strategic discussions.
Differentiate proposals and client solutions through expert-driven COA strategy narratives.
Translate emerging scientific and regulatory expectations into actionable client recommendations.
Regulatory-Grade Endpoint Strategy & FDA Engagement
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions.
Support preparation for and participation in FDA meetings as the COA subject matter expert.
Guide sponsors on evidence expectations, context of use, and fit-for-purpose COA strategies.
COA Instrument Development Leadership
Provide scientific leadership in the development of new COA instruments from concept to validation-ready tools.
Lead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches.
Oversee qualitative research activities supporting content validity, including concept elicitation and cognitive interviewing.
Ensure new COA instruments are patient-centered, scientifically robust, and fit-for-purpose for clinical and regulatory use.
Internal SME Oversight & Quality Assurance
Serve as subject matter expert overseeing internal project teams executing COA strategy and development work.
Review and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices.
Mentor and coach COA consultants, supporting capability development across the organization.
Business Development & Practice Growth
Support business development through proposal leadership, solution design, and client presentations.
Contribute to the evolution of COA strategy methodologies, frameworks, and reusable assets.
External Scientific Leadership & Visibility
Maintain a strong external profile through publications, conference presentations, and scientific collaborations.
Represent IQVIA as a recognized expert in COA science and endpoint strategy.
Contribute to academic teaching, advisory boards, or industry working groups where appropriate.
Essential experience, skills and education required
Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research.
Extensive experience developing COA endpoint strategies across multiple therapeutic areas.
Hands-on experience developing new COA instruments, including item writing and qualitative validation.
Experience supporting FDA-facing endpoint strategy and regulatory interactions.
Ability to mentor junior team members.
Excellent scientific writing, presentation, and stakeholder engagement skills.
Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred.
Strong publication record and recognized credibility in outcomes research or COA measurement science.
Well-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing.
An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same.
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