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.
Heraeus Medical GmbH sucht in eine/n Clinical Expert R&D (m/w/d) (ID-Nummer: 13555746)
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.
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 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.
Als treibende Kraft hinter bahnbrechenden klinischen Studien übernimmst Du nicht nur Verantwortung für Planung, Budget und Steuerung, sondern führst ein engagiertes Team von Experten zum Erfolg. In dieser Schlüsselrolle bist Du der Motor für Innovationen und sorgst dafür, dass unsere Vision einer schmerzfreien Welt Realität wird.
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.
In dieser neuen Rolle führen Sie eigenständig alle Aktivitäten, bestehend aus Bewertung, Planung, konzeptioneller Umsetzung und Implementierung sowie Überprüfung, Wartung und Stilllegung von studienspezifischen IRT-Konzepten.Sie agieren selbstständig als IRT-Vertreter*in in bereichsübergreifenden und funktionsübergreifenden Studien- und Projektteams und besitzen fundierte Expertise in der technischen Umsetzung von IRT-Konzepten und klinischem Studiendesign im Hinblick auf Compliance und Arzneimittelsicherheit.Sie tragen auch zur kontinuierlichen Weiterentwicklung von IRT-Konzepten bei, indem Sie neue Ansätze und Lösungen einbringen, um die Systeme auf dem neuesten Stand zu halten.Sie stellen sicher, dass alle Arbeiten unter Berücksichtigung der Patientensicherheit und in Übereinstimmung mit GMP und GCP sowie US-, EU- und anderen internationalen Richtlinien durchgeführt werden. Zusätzliche Aufgaben für die Expert-Rolle:Sie unterstützen bei den Aktivitäten zur Validierung von computergestützten Systemen. DAS BRINGEN SIE MIT: Anforderungen IRT Specialist: Masterabschluss in Naturwissenschaften und mehrere Jahre Erfahrung in einer verwandten wissenschaftlichen Disziplin oder Bachelorabschluss mit langjähriger Erfahrung in einem verwandten Bereich oder Erfahrung im Qualitätsumfeld.Erfahrung im IRT-Bereich, nachgewiesenes vertieftes Wissen über die technischen Aspekte und Funktionen eines IRT-Systems (von Vorteil).Gute Kenntnisse des generischen Software-Entwicklungszyklus, einschließlich der Validierung von Cloud-Systemen (von Vorteil).Gute Kenntnisse der regulatorischen Anforderungen und GMP/GCP-Vorgaben in der Pharmaindustrie und deren Anwendung auf die Funktion sind erforderlich.Gute Kenntnisse globaler investigativer Arzneimittelaktivitäten sowie allgemeiner klinischer Studienausführung und -design.Fähigkeit, komplexe Aufgaben eigenständig zu initiieren und zu analysieren, unter Berücksichtigung der geltenden Vorschriften, Wirtschaftlichkeit und Zeitpläne.Ausgezeichnete Kommunikationsfähigkeiten und fließend in Englisch, sowohl in Wort als auch in Schrift.
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.
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.
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.
Key Responsibilities Medical science expertise: Act as trusted scientific expert, delivering accurate and compliant scientific and clinical education to external stakeholders. Present complex data in a clear and compelling manner, in oral and written form.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
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.
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.
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.
Unser Team besteht aus 32 MTRAs, 13 Ärzten und 13 Medizinphysik-Experten. Zur Verstärkung unseres Teams suchen wir zum nächstmöglichen Zeitpunkt eine:n Medizinphysik-Experten (m/w/d) in Vollzeit.
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.
. • 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.
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.
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.