Description
Sr Project Manager/Data Modelling/Data Standards Metadata Business LeadReference No.: 917100NC
Role:Sr Project Manager/Data Modelling/Data Standards Metadata Business Lead
Location:Basel Und Region, Switzerland
Workload:100%
Start Date:From 01.02.2018
Duration:6 to 9 months plus
Tasks and Responsibilities:
-Responsible for Data modeling with respect to clinical data standards metadata
-Should be able to lead and organize team members within the framework of and overall project plan
-Should have good knowledge/experience of GxP systems development methodologies
-Should be able to understand clinical development process from protocol to submission
-Should be good in 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.
-Should be able to energize and work closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).
-Should have good experience with any clinical metadata modelling tool (eg. Akana, Sycamore MDR, etc)
Deliverables:
-Should be good experience/knowledge in 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 staff collaboration.
-Should be able to define the test cases for assessing the prototype
-Should be able to define the framework, content and scope of the test cases.
-Responsible to provide support to the client technical writing resources during test case development.
-Responsible for metadata model encompassing all aspects of data client want to hold, global, study and system information, global and protocol structures, trial design structures
-Responsible to 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 clients architects to the define the elements which support the clients operational data hub
-Responsible for Data standards governance concept document that explains how client may define and manage standards within the Clinical and Metadata Repository
-Liaise with the standards organization.
-Includes the facilitation of up to 2 workshops culminating in SOP/working practice documentation.
-Responsible to plan for migration of the current data standards metadata from clients Systems
Required Skills:
-Should have good experience in Data Management, or Clinical Trial Operations with a clear understanding of clinical data from internal as well as external sources.
-Must have good demonstrated knowledge of metadata management and pharmaceutical industry standards (CDISC).
-Should have strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential
-Should have good Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions
-Should have good demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics.
-Must have 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.
Nice to have : Experience in Pharma Domain.
Languages: Fluent in English and Good verbal command of German is a plus
Education: Bachelor's or Master's degree in relevant field
About us:ITech Consult AG is a certified ISO 9001 : 2008 Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
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