Principal Consultant, Consultative Services

Blue Bell, Pennsylvania

As a member of the Consultative Services team, you will be help our clients with implementation of CDISC standards and preparation for regulatory submissions. You will actively participate in the development of Pinnacle 21 tools. Also, you will leverage your domain knowledge and experience to promote Pinnacle 21 thought leadership

What you’ll be doing

Provide consultative services to P21 clients by helping them with:

  • Implementation of CDISC standards, including SDTM mapping, analysis datasets specifications, creation of define.xml files, etc.
  • Preparation for regulatory submissions, including guidance on requirements from regulatory agencies, evaluation of existing data packages for submission readiness, risk assessment and resolution of issues, and creation of submission documentation
  • Enhancement of company processes through analysis of existing practices and recommendation on their improvement
  • User training and knowledge transfer
  • Level 2 & 3 customer support, including analysis and resolution of reported issues

Participate in development of P21 tools by

  • Proposing and leading the implementation of new tools and enhancement of existing functionality
  • Developing, managing, and implementing validation rules for all data standards across regulatory agencies, including user-specific reports (e.g., FDA coreDF)
  • Testing of P21 tools through active use

Promote P21 thought leadership by

  • Preparing papers and presenting them at industry conferences
  • Conducting webinars
  • Writing blog posts
  • Assisting with preparation of white papers and training materials
  • Supporting P21 users on forums and social media
  • Participating in the industry initiatives like CDISC, PhUSE, HL7, etc.

What we’re looking for
If you meet these criteria...

  • Positive energy, working smart, getting things done and being a team player
  • Expert knowledge of industry standards and regulatory requirements
  • Experience in successful implementation of CDISC standards and preparation of study data for regulatory submissions
  • Willingness and ability for continuous professional development
  • US citizenship or green card, necessary to gain clearance for government contracts
  • Ability to travel 10% time

... then we’d love to hear from you

To Apply