Position Type:  Consultant

Purpose of Position:

CDISC recently launched the CDISC 360 project, which seeks to implement standards as linked metadata with a conceptual foundation providing the additional semantics needed to support (1) expression of the full meaning of clinical data through its expressed relationships to other clinical data; (2) a single, unified implementation of the CDISC Foundational Standards; and (3) metadata-driven automation across the clinical research data lifecycle.

CDISC 360 will develop proof-of-concept enhancements to the CDISC standards metadata as well as related proof-of-concept software to confirm that the enhanced standards can be used to automate preparation of study specification metadata and end-to-end study data processing.

The Technical Project Manager will provide project management services as described below to five workstreams engaging 40-50 professionals who are loaned to the project from other organizations. Services will primarily be related to the CDISC 360 project,however, may support other CDISC projects as identified by CDISC.

This is a 12-month, full-time contract position.

Responsibilities of Position:

  • Provide dedicated project-level project management support to Project Leads and Workstream Leads
  • Meet deadlines via oversight and facilitation of activities to progress the goals of the project
  • Develop and manage project management deliverables in partnership with Project Leads and Workstream Leads
  • Develop workstream charter
  • Develop and manage execution of a detailed Project plan including milestones, dependencies and resource requirements
  • Develop periodic status reports
  • Track and manage issues and risk
  • Perform ongoing management and maintenance of project management deliverables. Generate meeting notes and follow up as appropriate.
  • Work with Project Leads and Workstream Leads to jointly manage timelines against plans, track and manage issues and risks, refine scope as needed and facilitate appropriate interactions and approvals as needed
  • Facilitate/support team meetings to develop design of solutions, agree on approach for solutions, drive compromises, and help suggest strategy/direction for workstream
  • Escalate issues, as appropriate, when decisions cannot be made or the decisions are compromising the overall direction and succes of the Project
  • Confirm appropriate support in place to drive team meetings and identify any resource gaps
  • Onboard new member company resources to their workstreams
  • Generate presentations, present, and answer questions for internal/external stakeholder groups
  • Provide strategic support for roadmap planning and evaluation of potential opportunities (as needed)
  • Collaborate across workstreams as needed to support the overall project objectives.
  • Other related activities as identified by CDISC and the CDISC 360 Project Leadership team

Qualifications:

  • 8+ years project management experience in a technical environment
  • 3+ years software development experience in an Agile or Scrum environment
  • Certification in Project Management, Agile, Scrum, SAFe or similar body of knowledge (preferred)
  • Highly organized and self-motivated
  • Ability to work collaboratively across departments and ask the right questions and get the right details from highly technical and very busy people.
  • Excellent written and verbal communications
  • Commitment to integrity and team success
  • Comfortable working in a virtual office environment
  • Legally authorized to work in the United States

Technical skills and Other Capabilities

  • Microsoft DevOps or other Software development certification
  • Facility with Atlassian Wiki and Jira tools
  • General knowledge of clinical trial process
  • Clinical trials data standards experience (preferred)

Please send CV and cover letter to jobs@cdisc.org.