B. in Wirtschaftsingenieurwesen, Internationales Handelsmanagement, BWL, Supply Chain Management oder vergleichbarMehrjährige Berufserfahrung im GMP-regulierten Umfeld, idealerweise in der Pharmaindustrie oder pharmazeutischen Distribution z.B. als Compliance Manager, Regulatory Compliance Manager, GMP Compliance Manager / GMP Specialist, Project Manager / PMO Manager Quality & Compliance (m/w/d)Fundierte Kenntnisse in GxP, Quality Management, CAPA, Change ControlErfahrung im Projektmanagement (PMO-Strukturen)Sicherer Umgang mit SAP (idealerweise SAP BI) und MS OfficeSehr gute Deutsch- und Englischkenntnisse WIR GARANTIEREN IHNEN: Sie erwartet eine direkte Festanstellung bei unserem wertschätzenden Kunden.Um Sie bestmöglich bei unserem Kunden zu präsentieren, optimieren wir gemeinsam Ihre Bewerbungsunterlagen und bereiten Sie gründlich auf das Vorstellungsgespräch im Unternehmen vor.Damit Sie zu den besten Konditionen eingestellt werden, stehen wir Ihnen im Voraus zur Verhandlung Ihres Arbeitsvertrags beratend zur Seite.Darüber hinaus beraten wir Sie auch gern kostenfrei zu weiteren passenden Karrieremöglichkeiten.
Study Physician services Medical Content Oversight: Responsible for medical content in Clinical Trial Protocols (CTPs).Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams.Provides medical input for CTP updates. 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.
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
You’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas and in covering projects in Germany, Austria and Switzerland. Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.
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!
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas in Germany or the DACH region.
Cost Manager - Data Centers (m/f/d) We are seeking an experienced Cost Manager to oversee financial control and cost management for data center construction projects, ensuring accurate budgeting, cost forecasting, and value engineering while maintaining project profitability and stakeholder expectations.
Joining the Data Science & Advanced Analytics team provides the opportunity to work with large and complex data and methodologies in a fast-paced, ever-changing environment to support international customers. As a member of our team you can expect exciting international projects with interesting development perspectives. Why Join? Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care.