Phuse CSS Roles Responsibilites

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The purpose of this document is to define the Roles and Responsibilities of the principal participants in the PHUSE Working Groups Collaboration. Roles governed in this document are:

  • Steering Committee Member
  • Working Group Lead
  • Project Team Lead

PHUSE Collaboration Mission

The mission is to provide an open and transparent collaborative framework in a non-competitive environment allowing (but not limited to) industry, researchers, standards organizations, and regulatory agencies to share and discuss the implementation of data standards, improvements in communication, evaluation of processes, assessment of emerging technologies, and best practices for product submissions and review, all with the goal of improving the product development and review lifecycle.

Steering Committee Member Responsibilities

The Steering Committee is the highest level providing direction, governance and authority for all actions within the group. Members also serve as either a Working Group liaison or as a member of the Process or Communication sub-teams. Responsibilities include:

  • Facilitate discussions among regulatory reviewers and industry that inform and improve product submissions
  • Support an annual conference where collaborators come to together to summarize work accomplished and plan for future efforts
  • Establish infrastructure and operational processes which involves collaboration from all contributors in the decision-making and project development process
  • Establish and facilitate a continuing working relationship with external organizations (CDISC, Transcelerate, etc.) to ensure that projects have representation from external organizations when applicable
  • Process sub-team responsibilities:
  • Led by a Steering Committee member (s)
  • Develop and manage Steering Committee processes
  • Accept and facilitate review of all project deliverables and new project requests
  • Define processes for new project review, new deliverable review, hand-offs (if applicable) and other processes as necessary
  • Provide a framework for handoffs between project and appropriate organizations (e.g. FDA, SDOs) if applicable
  • Ensure that all processes and roles are well described and documented
  • Communication sub-team responsibilities:
  • Led by a Steering Committee member(s)
  • Members represent the working groups
  • Responsible for developing and managing communication within the Steering Committee, across working groups, and to external audiences
  • Outward communication of new projects and project deliverables
  • Ensure working groups have tools/processes to effectively communicate
  • Communicate information to the working group and project leads on a regular basis which could include processes, information about other projects, or upcoming activities
  • Work with working group/project leads to provide outward bound information about the working group activities (i.e. PHUSE newsletter, LinkedIn groups)
  • Working Group liaison responsibilities:
  • Member of the Working Group Leadership Team responsible for providing the connection between the working group projects and the Steering Committee
  • Support ongoing collaborative working and project groups throughout the year
  • Check with Working Group leads on a regular basis to ensure projects are aligned, moving forward, and have resources
  • Encourage and facilitate cross working group collaboration
  • Escalation path for any issues with working group or project activities

Working Group Lead Responsibilities

The Working Group Leads are responsible for all projects within their Working Group, working to ensure the success of each Project. They provide a single point of contact for Project Teams, and manage communications to and from the Steering Committee. There are usually multiple Working Group Leads for each Working Group, and can be referred to as the Working Group Leadership Team. Responsibilities include:

  • Manage and Prioritize Projects
  • Assure a well-defined, manageable project scope, capable of being accomplished within a pre‐determined timeframe
  • Assure goals of the project are attainable through a partnership within the context of the Collaboration
  • Assure the project will have at least two co-leads and sufficient participating members to ensure success
  • Communication
  • Provide an avenue of communication between the Steering Committee and the Project Leads to allow all Project teams to be informed of Project related information in a timely and appropriate manner
  • Work with Project Leads to understand any project issues that may affect the success of the project and raise those issues to the Steering Committee for further discussion if needed.
  • Bring all Project deliverables to the attention of the Steering Committee for approval before deliverables are published in the public domain

Project Team Lead Responsibilities

Project Team leads are responsible for the overall success of the project and for delivering project results within a timely manner. Responsibilities include:

  • Manage all Project Team activities
  • Organize and manage meetings
  • Set expectations for the team
  • Manage project tasks
  • Provide adequate communication
  • Ensure Project Team deliverables are provided in a timely manner
  • Create well reviewed and vetted deliverables
  • Ensure cross-functional input and subject matter expertise
  • Provide strategy for overcoming obstacles