Schwarz Corporate Solutions sucht in eine/n Consultant Medical Affairs (m/w/d) (ID-Nummer: 13719949)
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.
Löwenstein Medical Technology GmbH + Co. KG sucht in eine/n ERP Inhouse Consultant (m/w/d) Schwerpunkt Vertriebsprozesse (ID-Nummer: 13665700)
Löwenstein Medical Technology GmbH + Co. KG sucht in eine/n ERP Inhouse Consultant Schwerpunkt Supply Chain (m/w/d) (ID-Nummer: 13656209)
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Mit uns erhalten Sie die richtige Unterstützung für Ihren beruflichen Erfolg in Zusammenarbeit mit auf Ihre Branche spezialisierten Consultants. Dieses Know-how ermöglicht es uns, Sie individuell und passgenau bei der Planung Ihrer nächsten beruflichen Schritte zu unterstützen.
Main Accountabilities: ·Collection and analysis of data ·Identify areas of opportunity or problems within a supply chain environment ·Determine & analyze all costs to enable the daily management of effective & efficient deliveries so as to meet the pre agreed to KPI's ·Build models and run "what-if" analysis ·Provide support to teams to drive cost containment and/or cost reductions, delivery flexibility through development of comprehensive transport performance metrics ·Act as consultant to the design team during design phase for new business ·Translate defined strategies into specific goals, objectives and responsibilities ·Identify, review and implement processes to ensure operational efficiency and increased productivity Requirements: ·Ability to review and analyse data/results ·TMS experience would be an advantage ·Fixed and dynamic routing experience ·Advanced Microsoft suite knowledge ·Ability to function on a strategic level ·Excellent communication skills both verbally and written ·Business and financial acumen ·Build and maintain excellent relationships ·Fluent English ·Readiness to travel We offer: ·Work with professionals full of passion and willing to share knowledge ·A friendly workplace ·Real opportunities for development ·Private medical care ·Co-funded sport card ·Preferred life insurance conditions ·Co-funded vacation ·Christmas vouchers ·Participation in events supporting the local community
Consultant / Projektmanager Pharmaceutical Services (m/w/d) PS Direkt - Job perfekt Sie möchten Projekte im pharmazeutischen Umfeld aktiv gestalten und dabei fachliche Expertise mit organisatorischem Geschick verbinden?
The Role: We have an exciting opportunity for an enthusiastic Fertility Specialist/Consultant to join our busy clinic in Glasgow. We are excited to be able to welcome a new team member to the clinic. You will be a skilled professional with experience or have an interest in developing skills in assisted conception and have the desire to be part of the largest provider of IVF in the UK.
In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet!
Für unser Analytics & Consulting Team suchen wir zum nächstmöglichen Zeitpunkt einen erfahrenen Senior Consultant am Standort Frankfurt am Main oder München. Als Engagement Manager übernehmen Sie die Leitung für unsere vielfältigen Beratungsprojekte und sind zentraler Ansprechpartner für unsere wesentlichen internen und externen Stakeholder.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
SUMMARY: We are looking for an experienced and passionate Principal Consultant, Information Security (Cloud Security) to join our Information Security Services team! As being part of this team, you will provide end-to-end security consultancy on cloud application and infrastructure, building security into our IT solutions from very beginning.