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Specialist, Implementation Consultant

Location: Wayne, PA
Status: Full-time, Employee
*Local Candidates. Must be able to work unrestricted in US. No Agencies please.

This role will be engaged on implementations of ViewPoint (Submission Management, Submission Publishing, Content Management) as a business analyst and product expert. The role will require interfacing with clients as a central point of contact with responsibilities that may include, but are not limited to, the following:

Solution/Requirements Definition

  • Responsible for developing and documenting client’s business goals and Octagon’s solution
  • Understand and document client’s current working environment and processes
  • Facilitate sessions with clients in order to document project success criteria
  • Identify and document areas for process improvements through either the use of system functionality or through process reengineering

Solution Implementation

  • Work with client and internal project team members to develop comprehensive overall project implementation plans
  • Facilitate requirements analysis and process mapping sessions to capture client’s configuration requirements
  • Manage and/or perform system configuration activities
  • Regularly interface with product development team regarding system customizations/enhancements
  • Consult with client regarding the preparation of their technical environments
  • Manage validation script (OQ/PQ) execution at client sites as part of a project

Solution Deployment & Support

  • Prepare process documentation per Octagon's standard methodology
  • Prepare client -specific training materials
  • Conduct role-based ViewPoint training
  • Track system issues & enhancement requests
  • Work with senior technical team members to liaise between clients & technology vendors to effectively troubleshoot and resolve technical issues

The successful candidate will have a combination of the following skills/experience:

  • BS degree in Computer Science or related degree
  • Minimum 4 years of demonstrated success on engagements/projects such as software implementation, system integration and solution rollout
  • Minimum 2 years consulting experience
  • Experience with publishing and/or managing electronic Regulatory Submissions
  • Experience with industry leading tools such as Documentum, eCTDXpress, Insight, and/or CoreDossier
  • Experience with implementing systems in a validated environment and familiar with 21 CFR Part 11
  • Understand or exposure to Process Management, Resource Management, Issue Management concepts
  • Demonstrated consulting and business analysis skills with a strong customer service focus
  • Strong communication, interpersonal, facilitation, and presentation skills
  • Skilled at managing multiple tasks and lead teams across multiple projects
  • Ability to travel up to 50%

Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.

Octagon is an Equal Opportunity Employer with an outstanding corporate culture. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

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