Clinical Solutions Analyst
1 month ago
Primary Purpose / Regulatory Responsibilities:
A primary function of this position is to globally provide skilled Key User oversight of clinical
applications and data repositories, including system upgrades and change requests to be
implemented on timely manner and within budget.
The further key function of this position is to lead the implementation of data collection and
management solutions for clinical studies, ensuring appropriate requirements gathering, specification, selection and implementation.
Responsible for the oversight and management of Key User support for clinical
applications, system integrations, and data repositories.
Systems may include:
- Clinical Trials Management System (CTMS); Business Intelligence (BI) and
dashboards for CTMS; electronic Trial Master File (eTMF); Electronic Data
Capture (EDC)/ Thesaurus Management System (TMS) and underlying systems;
Clinical Outcome Assessment Repository (COAR); Metadata Repository (MDR);
Clinical Data Repository (CDR); Electronic Document Management System
(EDMS); and others
Oversee system upgrades and change requests and work in collaboration with
Information Technology (IT) in the System Development Life Cycle (SDLC) from
feasibility, gathering requirements to implementation, training and maintenance
Define the expected business outcomes that are supported by the application and any
required integrations including expected service level agreements.
Prioritize IT support, projects, change requests, and support the process of collection
and consolidation of projects in line with Global Clinical Sciences and Operations
(GCSO) and strategy with regards to IT project/budget planning.
Act as delegate of the Process Data Owner (PDO) in the creation, review, and approval
of system documentation.
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