Participates in planning and reviewing medical sections of Clinical Trial Reports. Qualifications Medical degree from an accredited and internationally recognized medical school. Typically requires a minimum of 5-7 years' experience in clinical medicine.
YOUR TASKS Implement quality methodologies and procedures at the buffer yards, ensuring strict adherence to the quality control plan Supervise the proper execution of various subprocesses at the buffer yards Inspect incoming components such as concrete tower segments and tower internals Conduct audits on the installation of tower internals within stored tower segments Perform final inspections of the concrete tower before handing over to the Project Management organization Identify, document, and manage non-conformities arising during storage at the buffer yards Report daily on the progress and quality status of construction activities Participate in cross-functional meetings within the concrete tower structure to support project execution Coordinate tasks and activities at the buffer yards with the global quality team YOUR PROFILE Completed vocational training in a technical field (e.g. construction materials testing, concrete technology, or similar); further qualification as a certified technician in civil engineering or quality management is an advantage Experience with concrete and/or quality procedures is an asset English proficiency at B2 level and strong communication skills German proficiency at C1 level Team-oriented mindset YOUR BENEFITS Nordex offers a range of attractive benefits – here’s a selection of what you can look forward to.
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!
Assist the clinical team with 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 for completeness.
Your key responsibilities include: Developing, implementing, and monitoring supply chain strategies to improve efficiency, reduce costs, and enhance overall performance Managing supplier relationships, including selection, performance monitoring, and contract negotiation to ensure on-time delivery and adherence to quality requirements Establishing and enforcing quality control procedures and standards across the entire supply chain, from raw material sourcing to final product delivery Conducting regular audits and assessments of suppliers and internal processes to identify improvement opportunities and ensure compliance with industry regulations and company policies Leading problem‑solving initiatives related to supply chain disruptions, quality issues, and non‑conformances by implementing corrective and preventive actions Collaborating closely with internal stakeholders such as production, engineering, and procurement to align supply chain and quality objectives with overall business goals Analyzing supply chain data and quality metrics to identify trends, forecast demand, and report on key performance indicators (KPIs) Driving continuous improvement initiatives across supply chain and quality management systems Your Qualifications: Completed degree in Aeronautical Engineering, Engineering, Supply Chain Quality, or a comparable qualification Professional experience in aircraft manufacturing, Manufacturing Engineering, Quality Management, and Supply Chain Solid knowledge of KAIZEN, Lean Management, Project Management, and Total Quality Management (problem‑solving methodologies) Proficiency in supply chain planning tools and enterprise resource planning (ERP) systems Knowledge of APQP (Advanced Product Quality Planning) Business‑fluent English skills and advanced German language skills Strong communication, interpersonal, and leadership abilities, with the capability to influence and collaborate across diverse teams Ability to work effectively in a fast‑paced and dynamic environment Proven ability to manage complex supplier relationships and negotiate effectively Excellent analytical and problem‑solving skills with a data‑driven approach Willingness to travel (approximately once per month) Wir freuen uns auf Ihre aussagekräftige Bewerbung
YOUR TASKS Implement quality methodologies and procedures at the buffer yards, ensuring strict adherence to the quality control plan Supervise the proper execution of various subprocesses at the buffer yards Inspect incoming components such as concrete tower segments and tower internals Conduct audits on the installation of tower internals within stored tower segments Perform final inspections of the concrete tower before handing over to the Project Management organization Identify, document, and manage non-conformities arising during storage at the buffer yards Report daily on the progress and quality status of construction activities Participate in cross-functional meetings within the concrete tower structure to support project execution Coordinate tasks and activities at the buffer yards with the global quality team YOUR PROFILE Completed vocational training in a technical field (e.g. construction materials testing, concrete technology, or similar); further qualification as a certified technician in civil engineering or quality management is an advantage Experience with concrete and/or quality procedures is an asset English proficiency at B2 level and strong communication skills German proficiency at C1 level Team-oriented mindset YOUR BENEFITS Nordex offers a range of attractive benefits – here’s a selection of what you can look forward to.
Conduct initial calculations and prepare business cases for Group Controlling. Create reports, analyses, and decision-support materials. Prepare internal and external presentations. Maintain accurate data in the CRM system.
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.
Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries. 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.
Champion consistent use of brand guidelines and support colleagues in embedding them. Support the delivery of key corporate reports, including our Annual Report. Help organise and deliver major events such as the annual Leadership Conference. What you’ll bring You’ll be someone with the ability to translate complex information into clear, engaging messages.
Check the correct pre-assembly of the tower internals in the concrete segments Conduct audits of the preassembly and assembly phases of the concrete towers Perform the final inspections of the concrete tower prior to the handover to the PM organization Detect, open and manage the non-conformities opened during the construction phase Check the quality methods and documentation used by the subcontractors on site Report on the daily progress of the status of the construction activities in terms of quality Participate in meetings with other areas within the concrete tower structure to ensure execution of the project Coordinate with the global quality team in terms of tasks and activities on site YOUR PROFILE Certificate of Higher Education in Engineering or similar Experience in Construction, experience with wind turbine assembly and construction activities desirable.
YOUR TASKS: Support the QM on technical non-conformities and to ensure compliance with ‘Management of Change’ requirements for reporting, developing solutions and implementation Support the SM for Quality Gate 1 and incoming goods inspections Assist the SM, QM and Civil PE on pre-erection anchor cage and foundation checks Support the SM and QM with collating and checking for completeness, before releasing the Pre-erection documentation, Statutory Inspections and reports Organise and support the Gate 23 process with the SM and QM Collate the necessary information for reporting and managing NCRs and Incidents in UPVISE/Service Now or the prevailing software management tool Maintain close contact with QM for ordering and tracking missing parts and Requisition Notes (RNs) Resolving quality deviations (de-snagging) to ensure not only a smooth handover to the customer but also a smooth operation over the WT lifetime.
Key Responsibilities Develop and maintain detailed project budgets, cost estimates, and financial forecasts for data center construction and infrastructure projects, tracking expenditures against approved budgetsPrepare comprehensive cost reports, cash flow projections, and value engineering analyses to optimize project costs while maintaining quality standards and technical requirementsCoordinate with project managers, contractors, and procurement teams to evaluate contract proposals, change orders, and variation requests while ensuring cost-effective project deliveryConduct risk assessments for cost implications, develop contingency strategies, and monitor market conditions affecting material and labor costs in data center constructionReview and validate contractor invoices, progress payments, and final accounts while maintaining detailed cost documentation and audit trails for financial complianceSupport procurement processes, tender evaluations, and contract negotiations to achieve optimal value while facilitating cost reconciliation, lessons learned, and knowledge transfer for future project Qualifications & Skills Bachelor's degree in Quantity Surveying, Construction Management, Engineering, or related field with several years of experience in cost management for data center or mission-critical facility projectsComprehensive knowledge of data center construction costs, industry pricing trends, and ability to interpret technical specifications for accurate cost estimation and budget developmentStrong financial analysis expertise with proficiency in cost management software, spreadsheet applications, and demonstrated ability to prepare detailed cost reports and forecastsExcellent analytical, communication, and stakeholder management skills with proven ability to negotiate with contractors and suppliers while managing cost-related project risksExperience with value engineering, life-cycle costing, and cost optimization techniques in complex construction environments with understanding of procurement processes and contract administration Jones Lang LaSalle SE Human Resources Ihr Ansprechpartner: Jan Bauermann Talent Acquisition Partner EMEA jan.bauermann@jll.com Location: On-site –Frankfurt am Main, DEU If this job description resonates with you, we encourage you to apply even if you don’t meet all of the requirements.
You will work closely with local management and collaborate with Group Compliance in Hannover, gaining both operational exposure and strategic insight. You will report to the Compliance Manager based in Copenhagen. The compliance scope is rooted in corporate insurance, where due diligence primarily relates to sanctions and integrity risk in connection with corporate clients, brokers/intermediaries, and relevant third parties.
Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract.Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries.Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection.Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates.Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g.
You will work closely with local management and collaborate with Group Compliance in Hannover, gaining both operational exposure and strategic insight. You will report to the Compliance Manager based in Copenhagen. The compliance scope is rooted in corporate insurance, where due diligence primarily relates to sanctions and integrity risk in connection with corporate clients, brokers/intermediaries, and relevant third parties.
YOUR TASKS: Support the QM on technical non-conformities and to ensure compliance with ‘Management of Change’ requirements for reporting, developing solutions and implementation Support the SM for Quality Gate 1 and incoming goods inspections Assist the SM, QM and Civil PE on pre-erection anchor cage and foundation checks Support the SM and QM with collating and checking for completeness, before releasing the Pre-erection documentation, Statutory Inspections and reports Organise and support the Gate 23 process with the SM and QM Collate the necessary information for reporting and managing NCRs and Incidents in UPVISE/Service Now or the prevailing software management tool Maintain close contact with QM for ordering and tracking missing parts and Requisition Notes (RNs) Resolving quality deviations (de-snagging) to ensure not only a smooth handover to the customer but also a smooth operation over the WT lifetime.
Check the correct pre-assembly of the tower internals in the concrete segments Conduct audits of the preassembly and assembly phases of the concrete towers Perform the final inspections of the concrete tower prior to the handover to the PM organization Detect, open and manage the non-conformities opened during the construction phase Check the quality methods and documentation used by the subcontractors on site Report on the daily progress of the status of the construction activities in terms of quality Participate in meetings with other areas within the concrete tower structure to ensure execution of the project Coordinate with the global quality team in terms of tasks and activities on site YOUR PROFILE Certificate of Higher Education in Engineering or similar Experience in Construction, experience with wind turbine assembly and construction activities desirable.
Drive improvement to eliminate unacceptable risk and to achieve the required safety standards cost effectively. Report back to senior management on the findings and corrective action taken. To action/follow up all near miss/accident reports and liaise directly with the HSE for all reportable incidents.
. • 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.
In this role, you will be part of the Product Management & Key Account Management team and report directly to the Team Manager Product Management & Key Account Management. The position is based in our Bucharest office and works closely with international colleagues within DKV Refund Service and the wider DKV Mobility Group.
In addition, you will support pricing controlling by creating relevant reports and analyses that help assess target achievement.You will take responsibility for monitoring and documenting implemented pricing strategies and prepare results in a target‑group‑oriented manner for internal stakeholders.