Compliance Project Manager/Business Analyst

PMO Partners, LLC
Cambridge, MA
28 Oct 2024

Vacancy expired!

Description of Role: Project Manager / Business Analyst for Capabilities will be responsible for planning, managing, tracking and reporting of all project activities related to key capability builds. In this role, the PM/BA will be assisting with aiding the compliance department develop and augmenting / improving the existing the overall compliance program. The position will work with key compliance stakeholders to develop the strategy and assist in the gathering requirements for the strategy, developing a resource and overall plan to enable the strategy and help with the implementation of some of the key compliance projects. The position will also work with the ePMO to follow and meet key project management processes and reporting requirements. The Project Manager / Business Analyst will partner closely with the Compliance Team and all key stakeholders to develop the strategy and assist in the gathering requirements for the strategy, developing a resource and overall plan to enable the strategy and help with the implementation of some of the key compliance projects in the Capabilities Portfolio. This activities will include but not limited to:
  • Assist in the development of the overall compliance strategy
  • Support change management activities related to the communication of this strategy
  • Develop an overall resource and project plans for the overall portfolio
  • Support develop of program requirements to support package selection efforts
  • Support PFI / RFP process as needed
  • Develop, define and document business processes that align with Compliance SOPs
  • Develop, define and document operational model and requirements
  • Facilitate and document IT architecture design
  • Support IT security / infrastructure review for new IT systems
  • Plan, manage, track and report on full system implementation lifecycle
  • Implement organizational change management approach, capturing and rolling out end user training and communication
  • Oversee and drive all project team management and controls in accordance with company’s Capabilities methodology (e.g., project planning, scope, issue and risk management, decisions tracking, meeting coordination and minutes, etc.)
  • Establish post implementation support processes
  • Ensuring long-term support models and roles are identified and trained (e.g., system administration, system owner, process owner, etc.)
The PM/BA will bring their expertise to bear in guiding business users through the capability build and managing to project success criteria through project dashboard/status updates, project plan management, stakeholder management, vendor management, schedule management, and tracking of key risks, issues, activities, and deliverables. The Project Manager / Business Analyst for will be responsible for the creation business process maps, business procedure documentation that capture the business, technical and operational requirements of the project. The PM/BA will manage the development of end user training and communication materials required to evangelize the implementation the capability. The PM/BA will utilize all Company IT SDLC project artifacts and processes, provide written project status for regular project, program and portfolio reviews.

Specific Projects / Required Experiences / Systems Experience Needed:
  • Experience managing and implementing life sciences Compliance systems or projects such as:
  • Experience with One Trust application
  • Developing a Governance, Risk and Compliance (GRC) program (Lextegrity)
  • Experience with transparency reporting (MediSpend)
  • Risk Management including vendor / 3rd party risk management
  • Global monitoring
  • Investigator and incident management
  • Consent Management
  • Website Cookie Management
  • Good Clinical Practice and Part 11
  • Experience partnering with business leads to evaluate and document business requirements and use cases
  • Experience managing successful projects including project dashboard/status updates, stakeholder management, vendor management, timeline management, and tracking of key risks, issues, activities, and deliverables
  • 4+ years working in a regulated pharmaceutical organization, CRO or FSP
  • 10+ years as a project manager and business analyst

    • Must Haves Skills:
  • Leadership of business capability development and IT system implementation projects
  • Ability to communicate effectively with stakeholders at all levels of a matrix organization
  • Ability to work in a collaborative team environment – willing to pitch in to achieve goals and maintain relationships with business leads, stakeholders, business users, technical team, validation, quality, and vendor resources
  • Ability to work independently and with minimal supervision
  • Demonstrated ability to establish and meet priorities and deadlines
  • Experience with timeline management and resource / capacity management
  • English as a first language or excellent written and spoken English fluency

    • Plusses:
  • Experience in Life Sciences Compliance
  • Smartsheet experience

    • Day to Day Responsibilities: The role will be responsible for managing a portfolio of projects in the Compliance area. The PM / BA will partner with Compliance leads to
    • Develop an overall program strategy and approach, including develop of a program and resource plan;
    • develop and document business use cases and functional requirements that support the successful implementation of projects.
    • perform requirements elicitation, documentation and traceability.
    • responsible for managing project scope, project schedule development, tracking and reporting
    • responsible for establishing regular project meetings that address requirements, project status and issue/risk remediation.
    • ID: #21819342
    • State: Massachusetts Cambridge 02138 Cambridge USA
    • City: Cambridge
    • Salary: Depends on Experience
    • Job type: Contract
    • Showed: 2021-10-28
    • Deadline: 2021-12-24
    • Category: Science/biotech