Urgent Position ||IVRS System Analyst|| Berkeley Heights, NJ || 6+ Months|| Skype/ In Person Interview
sunil Kumar
Hi Folks,
I hope you are doing great today.
Please send me the resume at su...@infosoftsystems.com
We are looking for a IVRS System Analyst in Berkeley Heights, NJ
Job Title : IVRS System Analyst
Location : Berkeley Heights, NJ
Duration : 6 months contractor and have a chance to extended
Job Description:
Scope:
This position manages the development and maintenance support of GMP Part 11
compliant IRT systems for clinical trials conducted by Celgene Corp. Working as
a key member within the IRT Central Management Team, the candidate will
proactively recognize and address any technical issues associated with data
capture and generation for IMSC’s IRT Systems. The incumbent is also expected
to consult with external vendors, GSMM, Biostatistics, Data Management and
other end users as applicable to procure, develop and manage systems according
to trial needs/Celgene standards with minimal supervision to deliver results
with high integrity.
Responsibilities include, but are not limited to, the following:
• Gathers, documents, and analyzes system business requirements according to
relative process and procedures.
• Ensures IRT specifications align with Protocol, applicable regulatory
requirements, and study team needs.
• Provides guidance to internal or external validation groups.
• Generates and reviews internal and external test plans/summaries to ensure
requirement objectives are adequately verified, as needed.
• Develops, reviews, and executes User Acceptance Tests while adhering to the
Celgene Good Documentation Standards..
• Initiates and manages Change Requests, as needed.
• Provides end user training and support.
• Ensures IRT systems maintain data integrity and meet regulatory compliance
requirements, including 21 CFR Part 11.
• Provides Project Management support on various initiatives.
• Troubleshoots technical issues and works with vendor and IT stakeholders to
resolution.
• Develops end user guidelines, training presentations, and manuals as needed.
• Reviews and/or revises configuration documentation.
• Assists with budgeting and approval of invoice payments for applicable
clinical protocols.
• Manages & maintains system related process documents, including policies,
workflows, forms etc.
• Communicates information to key partners as required.
• Responsible for completion of specific milestones associated with projects.
• Builds and leverages internal and external cross-functional relationships and
manages conflict / issues with Celgene project teams and external partners.
• May present at investigator meetings as required.
• Independently makes decisions to ensure the effective resolution of issues as
they develop.
Skills/Knowledge Required:
• Moderate/strong understanding of drug development process and regulatory
requirements for clinical trials.
• Strong project management skills such as; reviewing business proposals,
contracts, managing timelines while ensuring quality,.
• Strong understanding of System Development Life Cycle (SDLC).
• Strong understanding of capabilities / limitations of IVR/IWR technology
• Strong vendor management skills.
• Strong knowledge of randomization and study drug management processes.
• Moderate understanding of legislative and regulatory requirements with
respect to investigational drugs and supporting computerized systems.
• Strong knowledge of clinical protocol analysis and its application including
clinical study processes.
• Ability to drive multiple projects to deliver a quality system on time.
• Ability to interpret and identify potential data unblinding scenarios.
• Moderate understanding of relationship database practices.
Potential overnight and out of state travel maybe required.
Looking forward to hear from you!
Thanks & Regards
Sunil Kumar