Senior Consultant
ViewPoint Implementation Services

Location: Wayne, PA
Status: Full-time, employee

This role will be engaged on implementations of ViewPoint (Submission Management, Submission Publishing, Content Management) functioning as a senior business analyst, product expert, and/or project manager.  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

• Facilitate sessions with clients in order to determine and document project success criteria
• Responsible for documenting and communicating Octagon’s solution
• Understand and document client’s current working environment and processes
• 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
• Manage project activities, client expectations, and project team members to ensure success criteria are met within budget and on schedule
• Proactively manage project issues and risks throughout an engagement
• Manage “Change Order” process when assumptions change during the course of a project
• 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
• Proactively manage project financials with respect to budget tracking and effort / revenue forecasting

Solution Deployment & Support

• Manage/prepare process documentation per Octagon's standard methodology
• Manage/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
• Direct, guide, and mentor junior team members

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

• BA or BS degree
• Minimum 8 years of demonstrated success on engagements/projects such as software implementation, system integration and solution rollout
• Minimum 6 years consulting experience
• Exposure to Regulatory Submissions across paper and electronic formats.
• Experience with industry leading tools such as Documentum (or Documentum-based products), Insight, and/or eCTDXpress
• Experience with implementing systems in a validated environment and familiar with 21 CFR Part 11
• 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 leading teams across multiple projects
• Ability to work hands-on with team and drive progress to achieve big picture objectives and goals
• 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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