Wir sind auf dem Weg, eine bedeutende Veränderung zu realisieren – den Übergang einer dynamisch wachsenden Unternehmensgruppe mit etwa 10.000 Mitarbeitenden von einem selbst entwickelten ERP-System zu SAP S/4 Hana. Gesucht werden nicht nur SAP-Experten, sondern wahre Wegbereiter. Sie werden Teil eines Projekts, das nicht nur neue Standards setzt, sondern auch das Unternehmen grundlegend verändert.
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 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.
DHL focus is to be an outstanding industry leader in customer centrism, global reach and quality driven organization – to reach this we need outstanding employees. Your future role We want you who can act as the Finance expert and interpret financial results and trends to the Site Managers in the area Sweden North. You will be responsible for reporting and planning on site level and will analyze and interpret the financial results and balance sheet KPI`s for the sites.
You are a nursing expert and you already have obtained a professional qualification in your home country whilst contributing to health and nursing care? Alternatively, do you know someone abroad with a professional qualification in health and nursing care who would like to come to Germany and work here?
WHAT YOU WILL DO Interactions primarily involve presenting to or influencing business representatives or vendors Interact primarily in issues related to specific phases of work or technical issues Participate in project meetings to argue for the test relevancy Specify logical and physical test cases, starting scenarios and test scripts Set up and maintain test environments Evaluate automation potential and define setup for automation and analyze the requirement complexity and estimate the test effort Conduct test analysis and design Execute manual and automated test cases (dynamic testing) and check and assess test results and manage defects Provide expert advice, training and technical assistance Contribute to employees’ professional development WHAT YOU SHOULD HAVE 5-8 years of experience including 3+ years of testing with emphasis on analysis and problem solving skills Experience in software development, service management Experience in test script development Strong in testing (test analysis & design, test execution, defect management process) and test management Strong in VB/Java scripting development (for test automation) Good knowledge of automation framework design Strong conceptual thinking and sense of responsibility Solid in business communications and business focus (service, relationship and quality) Solid business communications knowledge State-of-the-art knowledge of test related technologies, processes, and practices WHAT IS THE PLUS POINT(S) Strong technical skill of Vb scripting or Java programming Good understanding of test automation framework and/or open source tool set Hands on web services / API testing also integration with Jenkins, GitHub and any ALM tool WHAT YOU WILL GET FROM US Great Team of IT Professionals with Global Working Exposure Meal Card and Flexible Benefits – Customized According to Individual Needs On-Going Professional and Technical Training and Certifications A Multicultural Environment in Modern Offices Choose Any Day for Your Vacation From Earned Public Holiday (Saturday and Ad Hoc) Smart Casual Everyday Global Internal Job Opportunities Available Within DPDHL Unlimited Outpatient Medical Home Office Possibilities Sounds good?
Projektmanager am Standort München, Stuttgart und Nürnberg (m/w/d) Wir suchen begeisterte Expert*innen für unser Projektmanagement Team am Standort München, Stuttgart und Nürnberg, die an einer Reihe von wegweisenden Projekten arbeiten.
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.
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.
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.
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.
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.