Clinical Solutions Analyst

1 month ago


Raleigh, United States Advanced Recruiting Partners Full time

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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