Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Collaborating with experts at study sites and with client representatives. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Das sind wir: Unter unserem Dach versammeln wir mehr als 2.200 Mitgliedsunternehmen. 17.000 Expertinnen und Experten engagieren sich ehrenamtlich bei uns. Sie machen den Bitkom zu Europas größtem Thinktank der Digitalisierung. 160 Kolleginnen und Kollegen organisieren und bündeln dieses einzigartige Knowhow von Berlin aus.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts on study sites and client representatives. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in health care.Minimum of two years of on-site monitoring experienceKnowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment.Good command of German and English.Flexibility to business travel up to 60% of working time.Driver’s license class B.
Your responsibilities might include: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files and completeness.Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams.May participate in departmental quality or process improvement initiatives.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in Cardiovascular development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CNS clinical development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
We are looking for an exceptional Board-Certified physician to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio, with an emphasis on Gene Therapy/Gene Editing platforms, and advance this dynamic and rapidly expanding area of clinical development.The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials in CAGT and especially in the areas of Gene Therapy/Gene Editing, who will be a champion for CAGT across IQVIA.The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise.
We are looking in Portugal country for a IT Local Manager to: WMS solution expert for implementation of migration projects Leads solution design and WMS configuration according with business requirements and ensure smooth implementation Analyze and perform functional requirements for new functionalities and Integration process with client and other applications.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles. Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs). Anticipating project risk and implementing mitigation strategies.
Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
Fachthemen-/Projektkoordinator (m/w/d) Experten. Talente. Persönlichkeiten Einfach exzellente Aussichten! Wir sind eine Marke der I. K. Hofmann GmbH und bieten die besten Jobs für Fach- und Führungskräfte bei renommierten Unternehmen.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
Plan and execute load assessment tasks for research, sales, and service-related projects using advanced aero-elastic simulation tools. Provide expert technical input to development projects by integrating real site-specific load insights. Prepare clear technical reports and documentation summarizing analyses and results.
Plan and execute load assessment tasks for research, sales, and service-related projects using advanced aero-elastic simulation tools. Provide expert technical input to development projects by integrating real site-specific load insights. Prepare clear technical reports and documentation summarizing analyses and results.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
Construction Engineer / Construction Manager in the Dismantling of Nuclear Facilities (m/f/d) Einsatzort: Ispra, Italien Kennziffer: 2025-1316 Arbeitszeit: Vollzeit (unbefristet) Aufgaben Planning of technical projects in the dismantling of nuclear facilities (domestic and international)Preparation of schedules, budget plans and resource plans, including monitoring them for compliance and taking appropriate countermeasures in the event of deviationsLeading the project team and leading project team meetingsExamination of externally prepared planning and application documents, specifications and tender documentsIndependent coordination with planners, surveyors/experts, executing companies and other parties involved in the planningOrganisation and participation in acceptance tests / factory acceptances, detection and intervention in the event of deviations as well as organisation and monitoring of commissioning and cold handlingReporting and participation in work consultations, schedule discussions and other discussions Profil Completed studies in civil engineering or completed training as a state-certified civil engineer. or Construction technician with experience or equivalentStrong technical understandingConfident appearance, negotiation skills, organizational talent and assertivenessSound MS Office skills round off your profileExcellent knowledge of English and Italian desirablePractical experience in construction works, dismantling, or operational nuclear engineering Willingness to travel to the project location in Italy at least once a month Wir bieten A crisis-proof full-time job with a permanent employment contractThe option of hybrid working including Homeoffice Holiday and Christmas bonusExtensive induction by experienced colleaguesA wide range of training and development opportunities in a secure group of companiesEmployee conditions with discounted offers, e.g.: Membership in over 4,500 fitness studios via EGYM Wellpass and job bikeConclusion of an attractive BU (occupational disability insurance) + company pension scheme Have we aroused your interest?
. • Work on material reconstruction of teeth for realistic visualization and simulation. • Collaborate with domain experts (orthodontists, clinical specialists and biomechanical engineers) to refine requirements and validate solutions. • Optimize computational geometry workflows for efficiency and accuracy. • Integrate solutions into production-ready pipelines and software tools. • Stay updated with the latest research in ML, 3D graphics, and medical imaging.
So kommst du in unser TEAM: Bitte richte deine Bewerbung an Clara Trautner (HR Expert). Hinweis: Diese Stelle wird im Auftrag unserer Tochtergesellschaft E360 ausgeschrieben. Mit dem Absenden deiner Bewerbung erklärst du dich damit einverstanden, dass wir deine Unterlagen zur weiteren Bearbeitung an unsere Tochtergesellschaften weiterleiten und sich diese bei dir melden darf.
Innerhalb unseres Analytics & Consulting Teams beraten wir mit unseren Commercial Analytics Experten Unternehmen der Pharma- und Healthcare‑Industrie in markt- und vertriebsstrategischen Fragestellungen. Unsere Expert:innen entwickeln für unsere Kunden maßgeschneiderte Lösungen – von Markt‑ und Wettbewerbsanalysen über Marktforschung und Forecasts bis hin zu Marktstrategien, Vertriebsdesign, Kundensegmentierungen sowie Performance-Messungen.
COMPANY Taking lead of the sensory agenda… Foodjob Nordic is looking for a senior Sensory expert with excellent people skills for a key role at Carlsberg. Based out of Denmark and France you will be leading the sensory agenda in Carlsberg with the support of your team and the global sensory community in Carlsberg.
Your Profile BSc/MSC/Ph.D Degree in Mathematics, Computer Science, Information Technology, Physics or Engineering.At least 5 years experience in the field of data analytics, data mining.Technical expert in the field of data analytics, data mining.Proficient in Python and SQL languages.Experienced with statistical modelling and data mining techniques.Strong problem-solving skills with ability to multi-task and manage multiple projects simultaneously.
You are expected to deliver technical and architecture design and formulate standards related IT monitoring landscape (Infrastructure, Application and Business Process). You will act as the SME (Subject Matter Expert) and 3rd level support and also provide technical consultancy to support the design and implementation planning of new infrastructure technologies.
Das Team Data Science & Advanced Analytics – mit Standorten in Frankfurt, Philadelphia, Mailand, Madrid, Athen, Warschau und Peking sowie einem Netzwerk von mehr als 300 Experten weltweit – ist das globale Kompetenzzentrum für Statistik und Data Science bei IQVIA. Das Team ist verantwortlich für die Entwicklung statistischer Verfahren und Methoden, die in Qualitätssicherungsprozessen, Datenimputationen, Datenprojektionen, Forecasting und vielen weiteren Bereichen für Healthcare‑Paneldaten eingesetzt werden, darunter Apothekenumsätze, E‑Commerce‑Daten, Krankenhausverbrauch, verschreibende Ärzte sowie longitudinale anonymisierte Patientendaten.
Strong experience with Lean methodology within the supply chain & Purchasing processes. An ERP/MRP subject matter expert, with strong data capture and analysis skills. Process Improvement Expertise: Proficiency in Lean, Six Sigma, or other process improvement methodologies.
You are expected to deliver technical and architecture design and formulate standards related IT monitoring landscape (Infrastructure, Application and Business Process). You will act as the SME (Subject Matter Expert) and 3rd level support and also provide technical consultancy to support the design and implementation planning of new infrastructure technologies.
Exceptional problem-solving and algorithmic thinking skills, coupled with a deep understanding of software design patterns and clean code principles. Expert-level knowledge and practical experience in building modern, scalable web applications using React, TypeScript, and advanced CSS/Styling techniques.
Exceptional problem-solving and algorithmic thinking skills, coupled with a deep understanding of software design patterns and clean code principles. Expert-level knowledge and practical experience in building modern, scalable web applications using React, TypeScript, and advanced CSS/Styling techniques.
To achieve this, we are looking for a Senior Product Manager who will shape the future of digital mobility and fleet management together with a cross‑functional team of engineers, designers, and subject‑matter experts. This is a rare career opportunity to build products used by hundreds of thousands of companies across Europe and to help shape the mobility of tomorrow in a dynamic and agile environment.