Plaease find the below urgent requirement from one of our clients


Need GC


*Job role: Business Analyst Lead*

*Location: Durham, NC*

*Duration: 6 months+*


*Job Description:*



The Business Analyst Lead position will analyze, document, and manage 
business requirements throughout the life of the project. This position 
will adhere to established System Life Cycle (SLC) and Computer System 
Validation (CSV) procedures, where applicable, in identifying innovative 
solutions that meet the specified requirements and add value to the 
business. As a member of project teams, the Business Analyst will 
facilitate communication and awareness of the standards and quality 
expectations of the stakeholders.




Perform requirements gathering and analysis in order to provide high 
quality and detailed requirements, ensuring the closest involvement with, 
and agreement from, the user community

Produce data/information models and preliminary system architecture, as 
needed, to provide an accurate, graphical representation, thereby 
facilitating successful solution design and development

Create prototypes and simulations to provide an accurate, graphical user 
interface representation, thereby facilitating successful solution design 
and development

Resolve conflicting end-user requirements

Follow System Life-Cycle (SLC) and Computer System Validation (CSV) 
procedures, as appropriate

Collaborate with the Lead User, or delegated member of the applicable 
business group, to create a User Requirements Specification (URS) document

Collaborate with the Development group to create a Functional Specification 
(FS) document

Assist with process modeling to clarify business requirements, and to 
enhance or re-engineer business processes, prior to, or in parallel with, 
solution design and implementation, as necessary

As needed, assist with the review of the Performance Qualification (PQ) 
document(s) prior to authorization and execution, to ensure that it 
incorporates previously-captured requirements, and includes tests or test 
steps that explicitly address each identified user requirement

Collaborate with Global IT Solutions functional groups by adhering to 
established processes to ensure that business requirements are delivered 
through successful project implementation of optimal, cost-effective 

Collaborate with developers to ensure adherence to business requirements 
and UI design specifications Develop training and support programs for 
global technology and process implementations, as needed

Assist in the gathering of initial Business Case requirements & other 
pre-project activities (e.g., high-level requirements, project scope, 




Strong technical and business writing skills

. Proficient in processing of safety information of clinical trial, post 
marketing surveillance and medical devices

Consults with multiple stakeholders (e.g. the sponsor / medical monitor / 
pharmacovigilance physician) to construct the system requirements

Handling of safety information according to given processes and procedures, 
by CPWW and/or client SOPs, WPs and Guidelines

Possess general working knowledge of PV regulatory frame work

Knowledge of medical terminology and of GCPs, ICH guidelines and FDA 
regulations with an emphasis in drug safety/pharmacovigilance.

Knowledge of technical and grammatical editing

Knowledge of best practices for user interface design

Ability to learn and use modeling languages when / where required

Ability to learn and use graphical design and prototyping tools when / 
where required

Negotiation and customer management skills

Ability to communicate technical concepts to non-technical audiences, and 
business concepts to technical audiences

Ability to develop training and support programs for global technology and 
process implementations

An understanding of current industry techniques for requirements 
elicitation, analysis, and specification

Ability to establish and maintain effective working relationships with 
co-workers, managers and clients




Candidates should possess a Bachelor's degree, and have a minimum of 3-5 
years of business experience, working

towards or holding applicable industry accreditation or certification; or 
equivalent combination of education, training

and experience; or equivalent combination of education, training and 


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