Klinisk sikkerhedsansvarlig
Kliniske sikkerhedsansvarlige er autoriserede klinikere, der sikrer, at de it-systemer til sundhedsvæsenet, som organisationen bygger, køber og tager i brug, er sikre for patienter. De driver processen for klinisk risikostyring, leder identifikation af farer, ejer fareregistre og skriver og godkender rapporter om kliniske sikkerhedsbegrundelser ved hjælp af standarder for klinisk risikostyring som ISO 14971 og IEC 80001-1.
Denne tekst er oversat fra engelsk af en AI-assistent og er endnu ikke gennemgået af en modersmålstaler. Citater fra den britiske regerings kompetencerammeværk for digitale og datarelaterede fag (UK GDaD PCF) og fra ESCO står fortsat på engelsk.
- Rolle i UK GDaD PCF
- Ingen: denne reference definerer rollen
- Erhverv i ESCO
- clinical informatics manager (ISCO-08 1342); regulatory affairs manager (ISCO-08 2619)
- På GitHub
- Roledokument · Roledata
Niveauer
| Lønramme | Rolleniveau | Niveau i UK GDaD PCF | Lønklasser i den britiske statsforvaltning | Point i jobvurderingen |
|---|---|---|---|---|
| 7 | Klinisk sikkerhedsansvarlig | — | — | 522 |
| 8a | Senior klinisk sikkerhedsansvarlig | — | — | 577 |
| 8b | Chef for klinisk sikkerhed | — | — | 619 |
I en organisation inden for digital sundhed og pleje
- Rollen skal varetages af en autoriseret kliniker, så sikkerhedsvurderinger hviler på aktuel klinisk viden og fagligt ansvar.
- It i sundhedsvæsenet kan skade patienter gennem forkerte, manglende, forsinkede eller vildledende oplysninger, så rollen vurderer risici, der ofte er skjult i data og arbejdsgange.
- Klinisk sikkerhedsarbejde løber gennem et systems hele levetid, fra design og udbud til ibrugtagning, ændring og udfasning.
- Nogle produkter er også reguleret som medicinsk udstyr, så rollen arbejder sammen med kolleger inden for regulering og kvalitet, hvor sikkerhedsbegrundelser og udstyrsdokumentation overlapper.
- Sikkerhedshændelser med it i sundhedsvæsenet kan forårsage alvorlig skade, så rollen undersøger hændelser og sikrer, at der drages erfaringer.
Erhverv og kompetencer i ESCO
ESCO opregner den viden og de kompetencer, som arbejdsgivere som regel har brug for (væsentlige) eller kan have brug for (valgfrie) til hvert erhverv. Brug dem som tjekliste til udviklingssamtaler.
clinical informatics manager
Clinical informatics managers oversee the daily operations of information systems used in a medical institutions. They also carry out research, using their understanding of clinical practices to find ways to improve healthcare services.
Væsentlige kompetencer og viden (28)
Færdigheder og kompetencer
- adhere to organisational guidelines
- analyse large-scale data in healthcare
- apply good clinical practices
- apply organisational techniques
- collect healthcare user's general data
- communicate in healthcare
- comply with quality standards related to healthcare practice
- conduct clinical software research
- contribute to continuity of health care
- contribute to public health campaigns
- follow clinical guidelines
- oversee clinical information system activities
- perform clinical coding procedures
- review patient's medical data
- use clinical assessment techniques
- use foreign languages for health-related research
Viden
Valgfrie kompetencer og viden (31)
Færdigheder og kompetencer
- advise on training courses
- communicate in foreign languages with health service providers
- comply with legislation related to health care
- implement strategic planning
- inform policy makers on health-related challenges
- manage budgets
- manage project metrics
- manage workflow processes
- meet deadlines
- participate in medical records' auditing activities
- perform project management
- recruit employees
- supervise staff
- train employees
Viden
- IBM InfoSphere DataStage
- IBM InfoSphere Information Server
- Informatica PowerCenter
- Oracle Data Integrator
- Oracle Warehouse Builder
- Pentaho Data Integration
- QlikView Expressor
- SAP Data Services
- SQL Server Integration Services
- analytical methods in biomedical sciences
- audit techniques
- conditions for professional practice of clinical psychology
- creation of clinical psychological opinions
- data extraction, transformation and loading tools
- health psychology
- healthcare analytics
- manage healthcare staff
regulatory affairs manager
Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the different phases of regulatory processes and act as an interface between business and government legislation or regulatory boards.
Væsentlige kompetencer og viden (26)
Færdigheder og kompetencer
- advise on efficiency improvements
- analyse legislation
- comply with legal regulations
- develop company strategies
- develop licensing agreements
- develop organisational policies
- enforce financial policies
- ensure compliance with company regulations
- ensure compliance with legal requirements
- ensure compliance with policies
- ensure products meet regulatory requirements
- identify legal requirements
- implement strategic planning
- integrate strategic foundation in daily performance
- interpret technical requirements
- manage relationships with stakeholders
- meet the requirements of legal bodies
- monitor company policy
- monitor compliance with licensing agreements
- organise business documents
- prepare licence agreements
Viden
Valgfrie kompetencer og viden (25)
Færdigheder og kompetencer
- advise on legal decisions
- analyse legal enforceability
- analyse scientific data
- communicate with banking professionals
- contact scientists
- identify hazards in the workplace
- keep updated on innovations in various business fields
- protect personal data and privacy
- provide legal advice
- support managers
Viden
- banking activities
- copyright legislation
- corporate law
- corporate social responsibility
- financial jurisdiction
- financial products
- hazard analysis and critical control points
- intellectual property law
- international trade
- law enforcement
- nuclear legislation
- patents
- procurement legislation
- quality standards
- tax legislation
Contains ESCO v1.2.1 data (https://esco.ec.europa.eu/). © European Union. Reuse authorised under Commission Decision 2011/833/EU.