ERP Test Manager

København

Introduction & Summary: We are seeking a seasoned Senior eTMF Business Analyst with specialist knowledge in Veeva systems and the clinical management system domain. Ideal candidates should possess a comprehensive understanding of eTMF platforms and exhibit technical proficiency alongside excellent communication skills. This role demands a self-starter who can work independently and collaboratively to deliver impactful solutions in a fast-paced environment. Main Responsibilities: Drive solution discovery by proposing pragmatic, compliant options. Perform impact analyses and support cost/effort trade-off discussions. Frame problems and design lightweight experiments for iterative solutions. Utilize data-driven approaches to validate problems and prioritize fixes. Conduct workshops and stakeholder interviews to uncover root causes. Lead communication, training, and change adoption activities. Key Requirements: Domain knowledge with experience in Veeva systems, preferably eTMF/Clinical Management System. Hands-on experience with eTMF features like document ingestion, metadata, and workflow management. Ability to drive solution discovery and analysis. Hypothesis-driven problem framing and solution iteration skills. Data-driven approach to metrics and validation. Strong stakeholder engagement skills. Independently manage end-to-end initiatives. Nice to Have: Experience working in an Agile setup. Ability to thrive in collaborative team environments.

Fredericia

emagine søger lige nu en erfaren projekt- eller programleder, der kan tage ansvar for et kritisk moderniseringsprogram for en af vores partnere i den finansielle sektor. Programmet omfatter modernisering af deres system til håndtering af værdipapirer samt omlægning af integrationer til en ekstern samarbejdspartner. Vi søger derfor en person, som kan navigere i komplekse projekter med mange leverancer, afhængigheder og teams i en agil organisation, og som kan sikre fremdrift, kvalitet og overblik på tværs af organisationen. Vi søger en kandidat, der har: Dokumenteret erfaring med ledelse af komplekse projekter eller programmer, gerne med modernisering af kritiske systemer Evne til at koordinere og styre mange leverancer med indbyrdes afhængigheder Stærke kommunikations- og samarbejdsevner – både skriftligt og mundtligt Resultatorienteret tilgang med fokus på både overblik og detaljer, når det kræves Kompetencer og erfaring: Program-/projektledelse i agil organisation Stakeholder management og risikostyring Koordinering på tværs af produktteams og tekniske teams Rapportering til styregrupper og ledelse Erfaring med AWS, systemintegrationer, udvikling eller arkitektur (foretrækkes) Kendskab til handelsplatforme eller værdipapir handel er en fordel Praktiske informationer: Opstart hurtigst muligt. Varighed i 12 mdr. Omfang fuldtid Lokation i Fredericia, med mulighed for lidt hybrid arbejdsform (forventeligt 3-4 dage onsite pr. uge i hele perioden)

København

We are seeking a System Manager to assist in the migration of an existing application stack from one data center to a newer, modernized facility. This is not a simple lift-and-shift operation; it necessitates a full system reinstallation on new infrastructure, along with thorough validation of the solution. Support will be provided by a Project Manager, but additional System Management expertise is required for the duration of this time-limited position. You will collaborate with the current System Manager and the Product Team related to the application. Main Responsibilities: Conduct IT risk assessments (ITRA) and ITRRA. Manage firewall and port openings, alongside segmentation requests. Execute ServiceNow system updates. Implement IT changes in a controlled manner. Document new software and hardware components in ServiceNow. Establish a verification plan and report for testing/validation. Perform installation verification (IV) and operational verification (OV). Handle IT incidents and problems related to data centers. Address deviations when necessary. Key Requirements: Strong background in System Management with execution and operational experience. Effective collaboration and alignment skills, ability to co-work with teams based in India and Denmark. Excellent communication skills in English. Knowledge of GxP regulations

København

We are seeking a highly skilled Clinical Data Scientist to join our team as a full-time consultant. You will combine deep clinical data expertise with pragmatic data engineering and analytic skills to generate actionable insights that inform clinical strategy and trial design. You will collaborate closely with clinical SMEs, biostatisticians, data scientists, medical experts, and engineers. Main Responsibilities As a Clinical Data Scientist, your core duties will include: Execute exploratory and confirmatory analyses on clinical trial and real-world datasets to inform clinical strategy and trial design. Design and implement complex data analysis plans and translate analyses into clear, actionable recommendations for clinical and product stakeholders. Rapidly prototype Minimum Viable Products (MVPs) and analytical workflows using agile practices and DevOps principles to iterate with users. Define cohorts, design subpopulation analyses, and perform robust quality assurance on outcomes and derived datasets. Ensure clinical concepts are correctly represented and harmonized across data models (CDISC SDTM/ADaM, OMOP, HL7); contribute to mapping and transformation logic. Produce reproducible code and well-documented workflows in Python, R, and SQL; collaborate with engineering to operationalize analyses on Databricks or similar platforms. Present findings and recommendations to stakeholders with clarity, tailoring communications to varying levels of data literacy. Key Requirements 3–5 years of hands-on experience working with clinical trial and/or real-world clinical datasets (EHRs, registries, claims). Strong applied experience in data analysis and reporting using Python, R, and SQL; production-ready, reproducible, and documented code. Experience with Statistical Modeling, Machine Learning, and Deep Learning. Familiarity with clinical data standards and transformations: CDISC (SDTM, ADaM), OMOP, and HL7. Experience with data standards mapping, CDISC implementations, or clinical trial design/operations. Experience with GitHub and Databricks or similar enterprise data platforms for scalable analytics and collaboration. Demonstrable experience defining cohorts, performing subpopulation/stratified analyses, and establishing QA checks for analytical outputs. Comfortable working with imperfect, heterogeneous clinical data and pragmatic about delivering timely, high-quality insights. Strong problem-solving skills, critical thinking, and meticulous attention to detail. Excellent verbal and written communication skills; able to convey complex analyses to clinical, technical, and product audiences. Results-oriented with strong ownership, learning agility, and collaborative mindset.