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: Site Monitoring, Good Clinical Practice, Site Management, Subject Recruitment, Regulatory Submissions
Madrid, Community of Madrid, Spain · Remote Solely
$45/hr–$80/hr
Senior
Anyone AI is recruiting skilled Full-Stack Developers to work on a project with a leading AI lab. Qualifications: Advanced professional written proficiency in English 3–7 years of professional software engineering experi…
Talent Community | Senior InRiver PIM Engineer ID76563
Madrid, Community of Madrid, Spain · Remote OK
Senior
AgileEngine is an Inc. 5000 company that creates award-winning software for Fortune 500 brands and trailblazing startups across 17+ industries. We rank among the leaders in areas like application development and AI/ML, a…
About Signify Through bold discovery and cutting-edge innovation, we lead an industry that is vital for the future of our planet: lighting. Through our leadership in connected lighting and the Internet of Things, we're b…
Skills: SAP, Microsoft Excel, Microsoft Office, Data Analysis, Market Analysis
Zamudio, Autonomous Community of the Basque Country, Spain · Hybrid
Mid level
Acerca de Nosotros: En GES (Global Energy Services) construimos proyectos de energía renovable, aportando soluciones en Ingeniería, Obras Civiles y Eléctricas, instalación de turbinas eólicas y operación y mantenimiento …
Skills: BESS Design, Electrical Equipment Sizing, Low Voltage Cable Calculation, Medium Voltage Cable Calculation, Trench Network Design
Opdenergy is a growing independent renewable energy producer (IPP) with presence in Europe, United States and Latin America with more than 21 years’ experience. The company develops, builds, finances, manages and operate…
Skills: ESG Reporting, Carbon Footprint Calculation, ISO 14001, ISO 9001, Microsoft Office
Permanent Part Time Research Nurse with Data Entry Experience in Oncology - Malaga (Spain)
Madrid, Community of Madrid, Spain · Remote OK
Mid level$525M raised
Permanent Part Time Research Nurse with Data Entry Experience in Oncology - Malaga (Spain) Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology…
Skills: Oncology, Data Entry, Clinical Research, GCP Certification, Venepuncture
Permanent Part Time Research Nurse with Data Entry experience in Oncology - Madrid (Spain)
Madrid, Community of Madrid, Spain · Remote OK
Mid level$525M raised
Permanent Part Time Research Nurse with Data Entry experience in Oncology - Madrid (Spain) Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology…
Skills: Oncology, Data Entry, Clinical Research, GCP Certification, Venepuncture
ÚNETE A LA NUEVA GENERACIÓN DEL RETAIL CON BALMOHK En la BALMOHK no vendemos ropa. Creamos un espacio donde las personas pueden expresarse sin filtros. No seguimos tendencias, creamos comunidad y movimiento. Somos una ma…
Skills: Store Operations, Stock Management, Logistics, Inventory Management, Loss Prevention
Job Description: Omega CRM, a leader in Technology Solutions, is looking to develop its Marketing practice with a Salesforce Marketing Cloud Consultant. Main duties: Investigate, create, and recommend innovative marketin…
Global Offer Manager - Enterprise Operations and Customer Service (Temporary)
Madrid, Community of Madrid, Spain · On-site
Senior
Locations: London | Madrid Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in busin…
Skills: Offer Management, Commercial Monitoring, KPI Tracking, Governance, Content Development
Job Summary: The Global Event Specialist supports the planning, coordination, and execution of global congresses, tradeshows, customer events, advisory boards, product launches, and strategic marketing initiatives that s…
ÚNETE A LA NUEVA GENERACIÓN DEL RETAIL CON BALMOHK En la BALMOHK no vendemos ropa. Creamos un espacio donde las personas pueden expresarse sin filtros. No seguimos tendencias, creamos comunidad y movimiento. Somos una ma…
Skills: Stock Management, Warehouse Organization, Loss Prevention, Inventory Management, Team Leadership
Are you ready to join our digital revolution journey? At Aleph, we’re not just part of the digital advertising landscape—we’re shaping its future. Representing the world’s leading platforms, including TikTok, Amazon, Goo…
Skills: SAP S/4HANA, SAP BTP, Program Management, Integration Management, SAP FICO
Contable Madrid Si eres Contable, y quieres trabajar en una multinacional líder en el sector, con más de 25 años de experiencia ¡Esta es tu oportunidad! En Diaverum España, buscamos profesionales comprometidos para unirs…
¿Estás buscando un nuevo desafío? ¿Te gustaría ayudarnos a dar forma al futuro de los seguros de coche? Prima podría ser el lugar ideal para ti. Desde 2015, hemos estado usando nuestra pasión por los datos y la tecnologí…
Skills: Claims Recovery, Insurance Law, Negotiation, Analytical Thinking, Microsoft Excel
¡Hola! Soy Mariana, recruiter de esta posición. Viajar es una de mis mayores alegrías, y lo que lo hace aún más especial es poder vivir esas experiencias con mi familia y nuestra querida gata Rosita. Quizás somos la déci…
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
bachelor degree
Posted 28d ago
~40 hrs/week
Responsibilities
Perform site monitoring visits and manage site activities to ensure study data is reported according to protocols and regulations. Coordinate subject recruitment, track regulatory approvals, and maintain essential study documentation in the Trial Master File.
Requirements
Requires a Bachelor's degree in a scientific or healthcare discipline and at least 2 years of on-site monitoring experience. Candidates must have strong knowledge of GCP and ICH guidelines along with proficiency in Microsoft Office tools.
Full job description
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 requirements.
Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications • Bachelor's Degree Scientific discipline or health care preferred. Req • Requires at least 2 years of on-site monitoring experience. Req • Equivalent combination of education, training and experience may be accepted in lieu of degree. Req • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. • i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Good therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good command of English language. • Organizational and problem-solving skills. • Effective time and financial management skills. • 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.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
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