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.
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.
Zur Verstärkung unseres Human Resource – Payroll Teams suchen wir Sie zum nächstmöglichen Termin als Senior Payroll Expert (m/w/d) Arbeitsort: Flexibel an einem unserer JLL Corporate Standorte mit der Möglichkeit hybrider Arbeitsgestaltung (Büro und Homeoffice).
Your Responsibilities: Support the resolution of complex quality issues and continuous improvement projects by defining measurement standards and identifying/facilitating improvements to increase: Process performance and product adherence to standards Reliability of dedicated processes Repeatability of processes during the initial design phase, prior to any process changes, and continuously throughout the product lifecycle Support Quality focal points for new development projects Support APQP deployment within the Quality scope Facilitate PFMEA (Process Failure Mode and Effects Analysis) Support the development of quality solutions/technologies within new development initiatives together with subject‑matter experts Support quality stream meetings and coordinate activities between sites and organizations Process Quality Management: Ensure consistent application of process management guidelines in line with the EN9100 standard Ensure the process referential (competences, resource models, documentation plan, process networks, deployment areas) is up to date, managed, and continuously improved Proactively support the Process Management Teams in managing the process referential and improving process maturity Ensure that any process change is properly addressed by checking the consistency of the changes and their impacts Collaborate with local and central Process Management Teams to improve Airbus Business Process Management Ensure implementation and effectiveness of process adherence by monitoring progress and collecting adherence results Ensure the quality of process deliverables and surveillance plans, and review process resources, performance indicators, compliance results, etc.
As part of the ABOUT YOU Group, SCAYLE unites a diverse team of experts from over 82 countries working in Hamburg, Berlin, and remotely across Europe. Global brands such as Manchester United, Deichmann, Fielmann, s.Oliver, FC Bayern, and Marc O’Polo trust SCAYLE to innovate and grow their businesses.
JOIN OUR TEAM IN COLOGNE FOR A FULL-TIME POSITION, STARTING AS SOON AS POSSIBLE. Expert “Automation Process Analyst (m/f/x)” in the Center of Digitization DO YOU HAVE PLENTY OF KNOWLEDGE AND WANT TO MAKE A DIFFERENCE?
You can therefore expect to: Identify user needs, design inputs and specifications through participation in the project start-up phase where interaction with key opinion leaders, doctors and other experts worldwide is crucial to fulfil the ambitious innovation targets Be a key influencer in significant development projects within Ambu, either through a mechanical design or lead role Develop new, and further improve existing, mechanical design solutions of components and assemblies as well as optimization of existing designs for Ambu's extensive product portfolio within endoscopy, anesthesiology, and patient monitoring Have the responsibility for the mechanical design and construction of functionalities, parts and assemblies including quality aspects for robust and safe medical products Translate technology concepts into fully working prototypes ready for feasibility testing and process evaluation including documentation Ensure that the component or product is manufacturable in high volume, fulfils function and stays within defined cost framework Ensure continually updated documentation in accordance with the regulations from FDA and ISO certification including FMEA's, risk assessments and tolerance analyses Trust cooperation with internal and external partners.
You have initial experience in the functional and disciplinary leadership of a team.You demonstrate strong analytical skills, particularly in profitability analyses, general evaluations, and variance analyses.You take responsibility for international initiatives and projects, for example to optimize planning and reporting processes.You act as a strong communicator and trusted advisor as well as a central interface for executive management, the executive board, and other internal and external stakeholders.You have very strong technical expertise, especially advanced Excel skills at expert level, experience in building BI dashboards, and HR KPI management.You communicate fluently and confidently in both English and German.You have solid knowledge of SAP FI/CO, including BW.
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.
WHAT YOU WILL DO Interactions primarily involve presenting to or influencing business representatives or vendorsInteract primarily in issues related to specific phases of work or technical issuesParticipate in project meetingsSpecify logical and physical test cases, starting scenarios and test scriptsSet up and maintain test environmentsExecute manual and automated test cases (dynamic testing)Check and assess test resultsManage defectsProvide expert advice, training and technical assistanceContribute to employees’ professional development WHAT YOU SHOULD HAVE: If you are highly motivated, creative and desire to start and develop your IT career in a fast-paced environment, you have come to the right place!
As part of our team, you will take on the following responsibilities: You take operational responsibility for identifying, correcting, and optimizing customer pricing conditions across all European sales organizations.You ensure price accuracy and compliance at customer and condition level – working closely with local sales teams and central commercial functions.You analyze large and complex pricing data sets to identify incorrect or inconsistent pricing conditions.You detect anomalies, errors, and deviations from pricing rules, guidelines, or strategic frameworks and develop systematic approaches to improve error detection and reduce manual effort.You execute price corrections, updates, and condition adjustments in SAP to ensure accurate billing and customer conditions.You work closely with the Pricing Strategy Expert to ensure alignment between operational price execution and strategic pricing principles.You support the translation of pricing strategy into operational rules, logic, and SAP configuration updates.You coordinate closely with European sales organizations, Sales Excellence, IT (SAP), and Commercial Controlling to ensure consistency, data quality, and transparency in pricing processes.You act as the central point of contact for countries regarding price corrections and operational pricing questions.You develop and maintain structured pricing data models to improve efficiency, transparency, and quality.You identify process gaps and implement improvements to optimize pricing workflows and reduce error rates.
Senior Expert PMI (gn) Vollzeit/ Teilzeit (hybrid) Your job at DKV Mobility? As part of a leading European B2B platform for on-the-road payment solutions, you will work in an exciting environment.
JOIN OUR TEAM IN COLOGNE FOR A FULL-TIME POSITION, STARTING AS SOON AS POSSIBLE. Senior Expert “Automation Process Analyst (m/f/x)” in the Center of Digitization DO YOU HAVE PLENTY OF KNOWLEDGE AND WANT TO MAKE A DIFFERENCE?
Your Mission As part of our AI platform team, you will: Work closely with AI Solution Architects, AI Engineers, and cross-functional technical teams to design, develop, and implement AI solutions across our products and services.Build and maintain a scalable, secure, and efficient infrastructure for our AI platform while continuously expanding your expertise in cloud services.Translate business requirements into functional AI solutions — guided by experienced colleagues in an agile development environment.Develop and maintain integrations between our AI platform (e.g., Conversational AI) and internal systems to support diverse business needs.Create demos and proof-of-concepts that showcase AI capabilities and promote AI adoption within the company.Act as a technical expert for our agentic AI platform, supporting other teams in leveraging AI and building their own solutions. What makes you stand out Degree in Computer Science or a related field.4+ years of experience in agile software development with solid understanding of the full engineering lifecycle.Hands-on experience with: Large Language Models (LLMs), Retrieval-Augmented Generation (RAG), MCP servers and Agentic AI systemsDesigning, building, and deploying advanced AI solutionsExperience with AI cloud platforms (e.g., Azure AI Foundry) and/or conversational AI platforms (e.g., Cognigy).DevOps experience, ideally within Microsoft Azure (ADO).Programming experience in at least one high-level language such as Python, Java, or TypeScript.Experience developing microservices using frameworks like Flask, Django, or Spring (Java).
You will report to the Quality Control Manager and operate as a senior specialist working closely with production, while maintaining functional independence from Production and Process Engineering. This is not a team-lead position, but a hands-on expert role with significant technical authority. Working hours & shift setup: The role starts on day shift. As production scales, FPRT will transition to 24/7 operations, and the role is expected to move into a three-shift rotation.
As part of our team, you will take on the following responsibilities: You work closely with AI solution architects, AI engineers, and other technical teams, supporting the development and implementation of AI solutions within DKV Mobility’s products and services.You help build and maintain a scalable and efficient infrastructure for DKV Mobility’s AI platform, continuously developing your skills and knowledge in cloud services.You support the transformation of business requirements into functional AI solutions — guided by experienced team members and working in an agile environment.You contribute to the development and maintenance of integrations between our AI platform (e.g., Conversational AI) and other internal systems to best support various business needs.You help create demos that illustrate the capabilities of AI and foster a deeper understanding of AI technologies within the company.You act as a technical expert for our agentic AI platform (e.g., Conversational AI) and support other teams in leveraging the platform and building their own solutions.
You will report to the Quality Control Manager and operate as a senior specialist working closely with production, while maintaining functional independence from Production and Process Engineering. This is not a team-lead position, but a hands-on expert role with significant technical authority. Working hours & shift setup: The role starts on day shift. As production scales, FPRT will transition to 24/7 operations, and the role is expected to move into a three-shift rotation.
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.
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.