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.
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 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 at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Your assignments Water treatment and desalination projects: study, design and supervision Short- and medium term assignments in English and/or French/Spanish speaking countriesCoordinate and expand desalination expertise within the organisation Your responsibilities Studies, design, tender documents and supervision for water desalination projects Being part of multidisciplinary teams Management of technical deliverables and reporting Your profile University degree in engineering or degree of similar level (B.Sc., M.Sc., PhD)At least 5 years of profound professional experience in desalination (SWRO)Experience with other technologies (MED, MSF), would be an advantage Experience in process and hydraulic engineering in water supply Experience relevant to assignments in developing countries desirableVery good command of the English and/or French/Spanish languagePrepared for worldwide travelling Flexible attitude We offer Interesting international projects (public and private Clients)Friendly international working environmentWorking in multidisciplinary teamshigh degree of personal responsibility Period of appointment: unlimited, the position is also available for freelance experts. Please send your application to Christina Müller. When applying for a job at GKW Consult, please note our information on data protection for applicants.
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 at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).
Join our expert team driving the future of renewable energy through advanced electrical simulation and grid integration. As Engineer Electrical Simulations & Models (m/f/d) , you’ll play a key role in developing and optimizing models that ensure our wind turbines meet global grid compliance standards.
Join our expert team driving the future of renewable energy through advanced electrical simulation and grid integration. As Engineer Electrical Simulations & Models (m/f/d), you’ll play a key role in developing and optimizing models that ensure our wind turbines meet global grid compliance standards.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Collaborating with experts at study sites and with client representatives. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Your Tasks Manage an interdisciplinary project team including engineering, production, and purchasing experts Deliver a cost-of-energy optimized technical system in close collaboration with all relevant functions Oversee all project phases from feasibility study to start of production in an international environment Ensure achievement of project goals regarding cost, quality, and timeline Apply professional project controlling using KPIs, progress evaluation, and deviation management Implement risk and stakeholder management throughout the project lifecycle Develop innovative approaches to reduce time-to-market and prepare decision proposals for management Your Profile Diploma or Master’s degree in Mechanical Engineering, Industrial Engineering, or equivalent Proven experience in engineering project management; PM certification is a plus Several years in the wind industry, ideally with drive train and nacelle expertise Strong MS Office skills, including MS Project Server; ERP and PLM experience advantageous Clear, structured communication and reporting skills; high quality awareness and assertiveness Intercultural experience and willingness to travel; fluent English, Spanish or German beneficial YOUR BENEFITS Nordex offers a range of attractive benefits – here’s a selection of what you can look forward to.
Your Tasks Manage an interdisciplinary project team including engineering, production, and purchasing experts Deliver a cost-of-energy optimized technical system in close collaboration with all relevant functions Oversee all project phases from feasibility study to start of production in an international environment Ensure achievement of project goals regarding cost, quality, and timeline Apply professional project controlling using KPIs, progress evaluation, and deviation management Implement risk and stakeholder management throughout the project lifecycle Develop innovative approaches to reduce time-to-market and prepare decision proposals for management Your Profile Diploma or Master’s degree in Mechanical Engineering, Industrial Engineering, or equivalent Proven experience in engineering project management; PM certification is a plus Several years in the wind industry, ideally with drive train and nacelle expertise Strong MS Office skills, including MS Project Server; ERP and PLM experience advantageous Clear, structured communication and reporting skills; high quality awareness and assertiveness Intercultural experience and willingness to travel; fluent English, Spanish or German beneficial YOUR BENEFITS Nordex offers a range of attractive benefits – here’s a selection of what you can look forward to.
Join our expert team driving the future of renewable energy through advanced electrical simulation and grid integration. As a Grid Simulations & Models Engineer (m/f/d) , you’ll play a key role in developing and optimizing models that ensure our wind turbines meet global grid compliance standards.
Join our expert team driving the future of renewable energy through advanced electrical simulation and grid integration. As a Grid Simulations & Models Engineer (m/f/d), you’ll play a key role in developing and optimizing models that ensure our wind turbines meet global grid compliance standards.
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.
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.
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.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in Cardiovascular 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.
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.
Key Responsibilities Medical science expertise: Act as trusted scientific expert, delivering accurate and compliant scientific and clinical education to external stakeholders. Present complex data in a clear and compelling manner, in oral and written form.