Sei dabei, wenn wir die nächste Herausforderung anpacken! Ab sofort suchen wir dich als Projektleiter / Consultant DMS-/ECM-Software (m/w/d) zur Verstärkung unseres Teams in Memmingen oder im Homeoffice. DU und deine Performance bei KUMAVISION In spannenden und abwechslungsreichen Projekten implementierst du DMS- bzw.
Sei dabei, wenn wir die nächste Herausforderung anpacken! Ab sofort suchen wir dich als Senior Consultant ERP-Software (m/w/d) zur Verstärkung unseres Teams in Mannheim oder im Homeoffice. DU und deine Performance bei KUMAVISION Als zentraler Sparringspartner und Kapitän steuerst du unsere Kunden in die Arbeitswelt von morgen und sorgst dafür, dass unsere Projekte ein voller Erfolg werden.
Sei dabei, wenn wir die nächste Herausforderung anpacken! Ab sofort suchen wir dich als Projektleiter / Consultant DMS-/ECM-Software (m/w/d) zur Verstärkung unseres Teams in Markdorf oder im Homeoffice. DU und deine Performance bei KUMAVISION In spannenden und abwechslungsreichen Projekten implementierst du DMS- bzw.
Sei dabei, wenn wir die nächste Herausforderung anpacken! Ab sofort suchen wir dich als Projektleiter / Consultant DMS-/ECM-Software (m/w/d) zur Verstärkung unseres Teams in Stuttgart oder im Homeoffice. DU und deine Performance bei KUMAVISION In spannenden und abwechslungsreichen Projekten implementierst du DMS- bzw.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
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!
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.
Conduct compliance investigations and anti-corruption reviews in conjunction with Internal Audit and external consultants, regularly reporting on such matters to the Group’s Code of Conduct Committee and professionally manage communications with regulators as may be deemed necessary. ...and any other duties required to assist in supporting the achievement of Group objectives.
Du bereitest Informationen adressatengerecht für Management und Gremien auf und bringst Dich in wechselnde Projekte ein. Dein Profil Das solltest du als Consultant Pricing & Costing (m/w/d) mitbringen: Du hast ein abgeschlossenes wirtschaftswissenschaftliches Studium – idealerweise mit Schwerpunkt Controlling – oder eine vergleichbare Qualifikation.