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EY Deutschland sucht in eine/n (Senior) Consultant Regulatory, Risk & Compliance Transformation Hub (Financial Services) (w/m/d) (ID-Nummer: 13117925)
Please apply with your English CV and motivation letter as well as your education certificates and job reference letters (Arbeitszeugnisse). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Please apply with your English CV and motivation letter as well as your education certificates and job reference letters (Arbeitszeugnisse). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Key Responsibilities: Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelinesMaintain central planning for document writing and QC deliverablesProvide recommendations for process improvements to enhance collaboration between CPP and document service teamsDrive document shell creation, QC processes, and timeline management Skills & Experience: Strong experience in writing full CSR for Phase 1 clinical pharmacology studies.
Please apply with your English CV and motivation letter. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Please apply with your English CV and motivation letter as well as your education certificates and job reference letters (Arbeitszeugnisse). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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.
Qualifications & Experience Advanced degree in Biostatistics, Statistics, or a related field (PhD preferred; Master’s accepted with significant experience).Proven experience working independently as a study statistician in late-phase (Phase II/III) clinical trials.Experience in pharmaceutical industry strongly preferred; CRO experience is a plus.Hands‑on expertise with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality‑of‑life measures.Demonstrated ability to implement complex statistical methods and guide cross‑functional teams through analytical decision‑making.Proficiency in SAS; working knowledge of R is advantageous.Experience with regulatory submissions and interaction with health authorities is a plus. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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.
Strong clinical research skills and commitment to evidence-based and patient-centered clinical development. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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.
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.
Qualifications Bachelor's Degree Related field OR 5-year relevant sponsor or clinical research organization clinical site contracting experienceGood negotiating and communication skills with ability to challenge.Strong legal, financial and/or technical writing skills.Strong understanding of regulated clinical trial environment and knowledge of drug development process.Good understanding of clinical trial contract management.Fluent in English and German language IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.