Persönliches Mentoring: Lerne von erfahrenen Expertinnen und Experten, die Dich individuell fördern und begleiten. Karriere mit Plan: Klar definierte Entwicklungsmöglichkeiten – vom Werkstudierenden zum Direkteinstieg und darüber hinaus. Team-Spirit und Wertschätzung: Arbeite in einer offenen, wertschätzenden Unternehmenskultur mit flachen Hierarchien und echten Teamspirit Innovations-Drive: Bring Deine Ideen ein und gestalte aktiv die Zukunft von Data-Driven Solutions und Visualisierungstools mit.
Persönliches Mentoring: Lerne von erfahrenen Expertinnen und Experten, die Dich individuell fördern und begleiten. Karriere mit Plan: Klar definierte Entwicklungsmöglichkeiten – vom Werkstudierenden zum Direkteinstieg und darüber hinaus. Team-Spirit und Wertschätzung: Arbeite in einer offenen, wertschätzenden Unternehmenskultur mit flachen Hierarchien und echten Teamspirit Innovations-Drive: Bring Deine Ideen ein und gestalte aktiv die Zukunft von Data-Driven Solutions und Visualisierungstools mit.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, logistics challenges, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
Risk-Based Quality Management: Defines medically critical data/processes and associated risks.Contributes to Integrated Quality and Risk Management Plan (IQRMP).Participates in risk discussions during trial conduct. Clinical Quality Monitoring: Co-authors Clinical Quality Monitoring Plan (CQMP).Aligns CQMP with IQRMP-identified risks and mitigations.
You will provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Key Responsibilities: • Perform, plan co-ordinate, and implement the following for complex studies: - The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing - The programming of analysis datasets (derived datasets) and transfer files for internal and external clients - The programming quality control checks for the source data and to report the data issues periodically • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams • Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies. • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables • Use and promote the use of established standards, SOP and best practices • Provide training and mentoring to SP team members Requirements: • Bachelor's Degree in Maths, Computer science, Statistics, or related field • 7+ years’ Statistical Programming experience within the Life Science Industry • Strong Efficacy experience • Advanced knowledge of statistics, programming and/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you • Global exposure • Variety of therapeutic areas • Collaborative and supportive team environment • Access to cutting-edge and innovative, in-house technology • Excellent career development and progression opportunities • Work-Life Balance, with a strong focus on a positive well-being Unleash your potential!
Your tasks: Ensure the provision of a safe and healthy working environment and ensure compliance with all company policies and procedures as well as client site policies, procedures and working arrangements as required Run the local Site according to the German local legal aspects in all matters Proactively engage stakeholders to ensure that on site clients expectations are met and exceeded On-site key point of contact for Facilities in the client’s premises Ensure vendors are well-managed, delivering services on time, within budget and according to HS&E guidelines Ensure that vendor procurement processes comply with agreed client procurement guidelines as well as Jones Lang LaSalle best practice Ensure financial processes are followed at all times Ensure all Critical Environment (CEM) requirements are met Ensure a property risk management program including audits is implemented and maintained Ensure disaster recovering and business continuity plans are implemented and maintained Ensure escalation procedures and incident reporting procedures are implemented and in place Your profile 5-10 years of Facility Management, Hoteling or Hospitality experience in similar corporate sites Excellent people skills and ability to interact with a wide range of client staff and demands.
. • Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan. • Develop and maintain relationships with investigational sites and support CRAs in site contacts. • In collaboration with Site Monitoring Lead and CRAs, ensure: o provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, customer SOPs, and adherence to trial protocol. o adequate trial supply distribution to sites. o continuous and timely data entry and cleaning, and on time Data Base Lock. o collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices. • Identify risks and contingencies and partner with project leader in problem solving and resolution efforts. • Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens. • Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.
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.
Ausbildung und Förderung der Mitarbeitenden in Abstimmung mit dem Bereich Human Ressources Sicherstellung der Kundenzufriedenheit Sie berichten an die Geschäftsführung und tragen im Führungskreis des Unternehmens gemeinsam mit Ihren Kollegen zur erfolgreichen Entwicklung unseres Mandanten bei Dienstsitz: Raum Frankfurt /M, bundesweit möglich Einstellungsdatum: schnellst möglich Gehalt: nach Vereinbarung Anforderungen Mehrjährige Erfahrung im Bereich der Führung von Vertriebsteams im Umfeld „Öffentliche Auftraggeber“ Belastbares Netzwerk zu Entscheidern, Planern und Beeinflussern im öffentlichen Sektor Mehrjährige Erfahrung im IT-Umfeld des öffentlichen Dienstes und ein ganzheitliches IT-Architektur-Verständnis Ausgeprägtes betriebswirtschaftliches Verständnis Ausgeprägtes Verständnis im Zusammenspiel der Themenbausteine Netzwerk, Security, IT-Management, Datacenter, Cloud und Collaboration Mehrjährige Management Erfahrung in der erfolgreichen Führung von Vertriebsteams Mehrjährige Management Erfahrung mit Umsatz- und Ergebnisverantwortung Strategische Kompetenzen in der Verkaufsplanung und Steuerung Unternehmerisch handelnde Persönlichkeit Tiefe Markt- und Branchenkenntnisse im Kontext der IT-Systemintegration Studium der Informatik oder einer verwandten Fachrichtung bzw. eine fundierte Ausbildung mit langjähriger praktischer Erfahrung im IT-Bereich Ausgeprägte Kommunikations und Entscheidungsstärke, Überzeugungskraft und Sozialkompetenz Hohe konzeptionelle, kreative und logische Fähigkeiten Ausgezeichnete Fähigkeiten im Bereich der Rhetorik, Präsentation und Moderation.
Statistical Analysis & Methodology Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross‑functional partners, pharma statisticians, or from finalized protocols.Implement non‑standard or advanced statistical methodologies, such as:Complex time‑to‑event analysesMMRM and other longitudinal modelsMethods aligned with estimands, including deep understanding of competing policies, assumptions, and analytical implicationsPerform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.