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CGI Technologies and Solutions, Inc. Electronic Content Management (ECM) Business Analyst in Plymouth Meeting, Pennsylvania

Electronic Content Management (ECM) Business Analyst

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Electronic Content Management (ECM) Business Analyst

Category: Business Analysis (functional and technical)

City: Plymouth Meeting, Pennsylvania, United States

Position ID: J1020-0360

Employment Type: Full Time

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Position Description:

The Electronic Content Management Senior Consultant should have 5-10 years of experience in Pharmaceutical, Biotech, and/or Medical Device Electronic Content Management accross one or more of the following areas : Clinical Data Management, Regulatory Information Management, Quality and Controlled Document Management. He/she must have experience as a Business Analysis workstream lead on projects and/or implementations requiring GxP Computer Systems Validation (CSV) and that folow the Solution Delivery Lifecycle (SDLC).

He or she must be comfortable and proficient in interacting directly with clients on an ongoing basis and managing their expectations. In addition, the candidate should be adept at eliciting business requirements, translating business requirements into system requirements, and managing clarifications between business and technical teams. Experience with data architecture and mapping for Clinical, Regulatory, and Quality processes is a differentiator, as is familiarity with Master Data Management and FAIR Data principles.

Your future duties and responsibilities:

• Provides subject-matter expertise and support to Electronic Content Management Projects and Business Development teams pursuing ECM work as needed in the following areas:

  • Clinical Data Management Systems

  • Clinical Trial Management

  • Electronic Trial Master File

  • CRO/Vendor Oversight

  • Study Start-up & Closure

  • Regulatory Information Management Systems

  • Registrations

  • eCTD

  • Submissions

  • Labeling

  • IDMP

  • Publishing

  • Quality Document Management Systems

  • Controlled Document Management (SOPs, Work Instructions, Master Records, Protocols, Specifications, Reports, etc)

  • Electronic Batch Records & Fillable Forms

  • Physical Records Management

  • Records Retention and Archiving

• Demonstrates facility in client-facing activities including:

  • Eliciting and documenting business requirements.

  • Analyzing and validating business requirements.

  • Translating business requirements into system and non-functional requirements.

  • Facilitating requirements review sessions with business and IT.

  • Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).

  • Assists in the creation of business cases and other related financial planning, impact identification, or value justification.

  • Consistently delivers on the following internal activities while fostering a collaborative environment:

  • Maintains and manages requirements within requirements management tool and related SDLC artifacts.

  • Performs or assists with defect or incident root cause analysis in support of RAID management processes.

  • Performs or assists with other functions including vendor coordination, planning, project management, release management and change management as assigned

  • Actively participates in special projects as assigned.

  • Adheres to Solution Delivery Lifecycle (SDLC) and IT Service Management (ITSM) processes.

  • Develops the right skills to meet the future needs of the organization.

  • Performs or assists with production support as needed.

Required qualifications to be successful in this role:

• Bachelor’s degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience

• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance Experience

• Ability to execute on highly complex assignments of variable size with minimal supervision and oversight

• Ability to coach and mentor others

• Excellent oral and written communication and interpersonal skills

• Highly organized

• Ability to analyze, articulate and solve problems

• Ability to learn quickly, move with agility between assignments, multi-task, and to work effectively in a team environment, both face-to-face and remotely

• Ability to manage small to medium sized teams across multiple projects


• Experience with Enterprise Systems implementations

• Experience executing roles within the SDLC (including author, tester, coordinator, or project manager)

• Requirements development, engineering or management knowledge

• Experience with enterprise requirements management / application lifecycle management tools

• Familiarity with Data Architecture and Mapping

• Understanding of Master Data Management practices and FAIR (Findable, Accessible, Interoperable, Reusable) Data principles.

Skill Set Years of Experience Proficiency Level

Business Analysis 4-6 High

Project Lead 3-5 High

Professional Services Consulting 2-4 High

What you can expect from us:

Build your career with us.

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At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.

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