Beschreibung
Responsibilities:
. Data modelling 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
o Lead development of URS & FS that are stored in Quality tool
o Lead development of Process workflows defined and documented in collaboration with staff collaboration.
. Definition of test cases for assessing the prototype
o Define the framework, content and scope of the test cases
o Provide support to the client technical writing resources during test case development
. Metadata model encompassing all aspects of data the client want to hold, global, study and system information, global and protocol structures, trial design structures
o 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
o Work with architects to the define the elements which support the operational data hub
. Data standards governance concept document that explains how the client may define and manage standards within the Clinical and Metadata Repository
o Liaise with the standards organization.
o Includes the facilitation of up to 2 workshops culminating in SOP/working practice documentation.
. Plan for migration of the current data standards metadata