Sandra Scheidl Email & Phone Number

Austria

Wien, Österreich

- Strategic and operative consulting for MPs, MDs and IVDs- Regulatory pathways for Europe and US- Conduct of clinical trials for MPs, MDs and IVDs, including Medical Writing, CPM, CDM, Biostats, Vigilance, Monitoring, Sample Management- Knowledge of ICH-GCP, ISO 14155, ISO 9001, ISO 13485, ISO 14971

Wien, Österreich

Wien, Österreich

Clinical Project Management•Complete oversight of the clinical trials and report to the Management Board•Monitor the progress of delegated clinical trials, which includes budgets and timelines•Prepare, oversee, and review documents that are related to the clinical study, like for example CSP, IB, IC, etc.•Development and preparation of submission package for ECs and/or CAs•Resource Management•Review and approve contracts and invoices•Issue resolution and/or improvement initiatives•Analysis, summary, and reporting of data for regulatory needs and/or for study data presentationsQuality Management•Own, challenge and continuously improve the existing Quality System •Ensure all documents and procedures are in place and kept current •Communicate with critical suppliers•Development, maintenance and follow ISO procedures (13485) and GMP requirements pertaining to medical devices responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures•Responsible for managing QC Inspection, document control personnel & processes, Calibration Process, Quality Management System (QMS) Training Process and Management Review•Responsible for QC Incoming Inspection•Coordinate with external consulting resources as needed•Manage the Internal Audit, CAPA program and Supplier CAPA program•Responsible for hosting regulatory 3rd party audits: Notified Bodies, FDA, etc.•Oversee the Corrective and Preventive action process, coordinating CAR root causes and corrective actions for both in-house and customer returns and complaints, with follow up checks to verify implementation.•Management of supplied material quality issues. Working with suppliers to ensure issues are effectively resolved and investigations are fully documented•Management of the complaint process, Medical Device MDR/MDD Vigilance assessment and reporting to CA•Investigate and implement effective corrective and preventative actions (CAPA).

Vienna

- Perform electronic data capture systems (EDC) database setup for clinical studies including specification, programming, testing, maintenance and customer training according to Standard Operation Procedures and project timelines- Data cleaning, Database lock and Data Transfer to Biostatistics- Acquire fundamental knowledge of customer needs/preferences, address issues promptly, and propose solution to recurring problems. - Standardization of CRF implementation, including processes from Study Start to Study Close- Quality Assistant, work with metrics

Vienna

Strategic Partnership:• Work with stakeholders to help them understand their requirements within the scope of a project• Gathering requirements via brainstorming, analyzing documents, running focus groups, collecting input via surveys and questionnaires, analyzing system interfaces, interviewing stakeholders and subject matter experts, observing real-time activities and work environment, facilitating requirements workshops, or reverse engineering existing systemsPlan and Build:• In collaboration with the business and other IT teams, analyze and design innovative solutions that are aligned with long-term strategy• Document and analyze business inputs, model the business domain (using process diagrams, flowcharts, and data models) and explore behavior models (use case, user experience design, storyboards, wireframes, user profiles and user stories)• In collaboration with data architects, develop necessary information models• Refine information models by working with the business to develop data definitions, categorization and classifications • Perform gap analysis, conduct feasibility studies and verify and confirm requirements• Help stakeholders select the solution that best fits their requirements by using assessment tools, evaluating alternate solutions, determining quality assurance mechanisms, and crafting and assessing an RFP• Manage issues, risks and requirements; resolve conflicts; gain approval through governance processes and track requirements through to business case approval• Ensure that applications and systems are in compliance with current and emerging regulationsRun: • Provide budgeting and forecasting data for support of existing systems, license requirements and projects in association with stakeholders and IT leader• Provide input and recommendations on system support resource needs

Vienna

• Provide ERP functional support and expertise to customers, end users.• Work within Technology Department to bridge JD Edwards requirements and business rules with Information Technology solutionsManages Configuration and testing of ERPAnalyze business processes. Identify, evaluate, develop and/or redesign systems and procedures to meet user requirements. Create detailed written user requirements for developers. Provide consultation to customers on business process redesign. Assist in the development of system documentation and training materials as well as training processes• Supports, drives and assists in all phases of JD Edwards implementation, including recommendation of modifications/customizations and enhancements to JD Edwards.• Documents requirements, functional specifications, development/programming specifications, feature lists and business rules by following SDLC• Creates focus and direction to business logic development and presentation through efficient communication, facilitation of constructive discussion, consensus building and end user validation• Assists customers in the development of test scenarios and troubleshooting of ERP defects

Vienna

Perform electronic data capture systems (EDC) database setup (ie. Medidata, Datatrak, Inform, OPVerdi, etc) for clinical studies including specification, programming, testing, maintenance and customer training according to Standard Operation Procedures and project timelines.Acquire fundamental knowledge of customer needs/preferences, address issues promptly, and propose solution to recurring problems. Interact with Contract Research Organizations (CROs), laboratories and technology vendors to support database setup.Standardization of CRF implementation, including CDISC Standards and processes from Study Start to Study Close.

Vienna

Vienna

Vienna

Master Of Science (Msc), It In Healthcare And Life Science

Matura, Netzwerktechnik Und Telekommunikation

Ausbildungsschwerpunkt "Telekommunikation und Netzwerktechnik"