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Metadata Business Lead (Level III) - Clinical Trials
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support, Design
Projektbeschreibung
We are recruiting for a level III Metadata Business Lead for our Pharmaceutical client in Basel on an assignment period of 9 months. This is a Datamodelling position with regards to Clinical Trials.
Responsibilities:
- Datamodelling with respect to clinical data standards metadata
- Able to lead and organize team members within the framework of an 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)
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
- Definition of test cases for assessing the prototype
o Define the framework, content and scope of the test cases
o Provide support to technical writing resources during test case development
- Metadata model encompassing all aspects of data, 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 to define and manage standards within the Clinical and Metadata Repository
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
Please get in touch with Luchele Mendes for further details
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Responsibilities:
- Datamodelling with respect to clinical data standards metadata
- Able to lead and organize team members within the framework of an 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)
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
- Definition of test cases for assessing the prototype
o Define the framework, content and scope of the test cases
o Provide support to technical writing resources during test case development
- Metadata model encompassing all aspects of data, 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 to define and manage standards within the Clinical and Metadata Repository
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
Please get in touch with Luchele Mendes for further details
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges