Beschreibung
Program Manager - Data Standards Metadata Business Lead (Ref. HS2361)
BRINE SA is currently looking for a Program Manager - Data Standards Metadata Business Lead.
We are offering a position for a candidate with following experience as Program Manager - Data Standards Metadata Business Lead.
Key Responsibilities
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Experience with any clinical metadata modelling tool (eg. Akana, Sycamore MDR, etc) (Pharma know-how required)
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Data modelling with respect to clinical data standards metadata
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Able to lead and organize team members within the framework of and overall project plan
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Knowledge of GxP systems development methodologies
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Understand clinical development process from protocol to submission
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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.
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Able to energize and work closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements).
Skills
- Experience in Data Management, or Clinical Trial Operations with a clear understanding of clinical data from internal as well as external sources.
- Knowledge of metadata management and pharmaceutical industry standards (CDISC).
- Knowledge of regulatory requirements supporting clinical trials and submissions
- 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
- Data standards governance concept document that explains how client may define and manage standards within the Clinical and Metadata Repository
Please send your CV ASAP in Word format to Brine SA.
Location: Basel
Start: ASAP
Duration: February 1st 2018 to July 31st 2018
Workload: 100%
Language: English/German an asset
Salary: Local Market rate according to experience
Ref: HS2361
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer profis and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014