Beschreibung
Projekt Nr.: A5816Startdatum: sofort
Branche: Dienstleistungsunternehmen
Dauer: 6 Monate mit Option
Einsatzort: Basel
Publiziert am: 22.01.2018
Mögliche Vertragsarten: Berater, Verleih
?https://www.ghrgroup.ch/de/kandidaten/vakanzen/details/orderNr/A5816.html
Beschreibung
Für unseren Kunden suchen wir einen sehr erfahrenen Data Standards Metadata Business Lead wie folgt (English):
Job Responsibilities
? Data modeling with respect to clinical data standards metadata
? Able to lead and organize team members within the framework of and overall project plan
? Knowledge of GxP systems development methodologies
? Understand clinical development process from protocol to submission
? Progressing CDISC aligned clinical data standards (data review, data collection, ADAM, SDTM) with a governance structure for ensuring consistency and compliance across Therapeutic Areas and with our CROs to support the exchange of data.
? Able to energize and work closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).
? Experience with any clinical metadata modelling tool (eg. Akana, Sycamore MDR, etc)
Qualifications
? Experience in Data Management, or Clinical Trial Operations with a clear understanding of clinical data from internal as well as external sources.
? Demonstrated knowledge of metadata management and pharmaceutical industry standards (CDISC).
? Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential
? Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions
? Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics.
? Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress
Deliverables
Business workflows, URS and FS oversight
? Lead development of URS & FS that are stored in Quality tool
? Lead development of Process workflows defined and documented in collaboration with client staff collaboration.
Definition of test cases for assessing the prototype
? Define the framework, content and scope of the test cases
? Provide support to the client technical writing resources during test case development
Metadata model encompassing all aspects of data client want to hold, global, study and system information, global and protocol structures, trial design structures
? Work with relevant stakeholders to define the elements which would support the CDISC standards for , trial design, and other required SDTM and ADaM data structures
? Work with client architects to the define the elements which support the client operational data hub
? Liaise with the standards organization.
? Includes the facilitation of up to 2 workshops culminating in SOP/working practice documentation.
Anforderungen
? Datenarchitekt ein Muss
? Data Warehouse Designer ein Muss
Sprachen
?Englisch sehr gut ein Muss
?Deutsch sehr gut von Vorteil
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG
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Web: ?http://www.ghrgroup.ch
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