Job Description :
Any visa/tax term

Clinical/Bio/Pharma Business Analyst

Work Location: Sunnyvale, CA

6 months+ CTH

General Position Summary/Purpose:

Client is seeking an IT R&D Business Analyst who will be responsible for
developing relationships with R&D stakeholders, surfacing unmet IT needs
and change requests, and managing portfolios of GxP systems and R&D IT
projects. The individual will serve as a strategic IT liaison to the R&D
organization and will translate their requirements into technical solutions
and processes. The individual will be expected to actively gather
requirements and communicate with Business Partners to assure their
understanding of existing tools, projects, and future directions will meet
their business needs. The individual will focus on building strong
partnerships and delivering strategic and meaningful Enterprise level R&D
IT solutions. The position will capture business problem statements and map
business processes to evaluate the solution
.
Key Accountabilities/Core Job Responsibilities:

Lead requirements gathering efforts and translate Business Requirements
into system Functional, non-functional, and operational requirements.
Identify areas of improvements with a focus on business systems and
translate these opportunities into technical solutions.
Facilitate and manage group requirements review sessions
Assist in product solution identification, evaluation, selection,
implementation, testing, and working with the IT Delivery Team(s) in
delivering the business requirements.
Work closely with Project Managers to develop/review/finalize Statement
of Work, Project Objectives. Assume responsibility for project tasks and
ensure they are completed in a timely fashion.
Develop the technical documentations for IT solutions delivery, such as
Stakeholder Requirements, Functional Requirements, Process documentation,
Transition Requirements, Training Documents, Testing, etc
Generate Test Plan, Use Case Scenarios, Test Cases, and conduct User
Acceptance Testing with business partners, perform System Overview and Risk
Assessment.
Identify and recommend business process improvements and develop system
roadmaps.
Provide data stewardship and governance within R&D.
Support and provide guidance to help the business adopt new methodologies
and technologies.
Interface with business and functional teams providing strong analytical
and problem solving skills.
Work closely with the IT platform leads to apply standards and evolve
process to ensure solutions abide by best practices and industry principles
and to help the business mature and scale.
Assist in developing user and system administration procedures.

Qualifications and Requirements:

7-10 years minimum experience in the Information Technology field
* 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting
R&D as a business analyst

* Strong knowledge of processes and applications related to Clinical
Operations, Medical Affairs, Clinical Data Management, Clinical Science,
Biostatistics, Drug Safety & Pharmacovigilance, and R&D (e.g. Oracle Argus,
BioClinica, IRMS, CTMS, JReview, SAS, Empower 3, SLIM, Masshunter
GCFID/MSD, LC/QTOFMS, TGA, DSC, TIAMO, Veeva Vault eTMF and RIM,
MasterControl, ComplianceWire, Axway Activator, SaveAsPDF, OpenLAB ECM,
OMNIC, Vaisala, Safely Alert Portal, *

* Knowledge of procedures and best practices related to FDA, EMA, GxP,
CFR21 Part 11, Computer System Validation, Sunshine Act, HCP Transparency
Reporting, and other regulations governing drug development and
commercialization
Experience with SOP authoring relative to R&D processes and applications.
Ability to articulate complex technical problems and business value to a
wide business audience.
Excellent verbal and written communication skills.
Ability to organize and present ideas in onvincing and compelling
manner.
Ability to troubleshoot issues and work independently with minimal
direction.
Self-motivated with high degree of initiative and excellent follow-up
skills, along with strong analytical and problem-solving skills.
Bachelor''s degree in business, computer science or related discipline.