Responsible for the successful planning, execution, management, change control and delivery of numerous concurrent complex infrastructure and computer system projects within the IT Department and across Alimentiv Product Lines, following Project Management Institute (PMI) - Project Management Professional (PMP) best practices.
Develop, implement, monitor and be accountable for project operational plans, risk management, resources, project tools/materials, documents, training and timelines. Ensure alignment with corporate policies and procedures and industry standards, sponsor, and regulatory requirements while maintaining transparent working relationships with cross-functional teams, vendors and partners
Project Management
- Manage the planning, execution, progress and completion (project lifecycle) of assigned IT and complex systems projects.
- Create and present accurate estimates of effort, costs and timescales for proposed projects and assist in prioritization.
- Define Project Charter (e.g. project objectives, scope and deliverables) and confirm alignment with business and system strategies.
- Secure and coordinate the necessary resources for projects by working with system owners, technical system experts and/or appropriate line managers, including any vendor or third-party resources.
- Ensure project activities adhere to project management methodologies and industry standards, applicable regulations, guidelines and corporate policies and procedures - including appropriate meeting minutes, documentation and controls.
- Review project costs and alignment with project budgets.
- Identify and assess project risks and determine mitigation strategies in coordination with stakeholders.
- Manage other corporate projects and initiatives, requiring PMP best practices, as defined by the strategic needs of the organization (e.g. mergers and acquisitions, office relocations or openings).
Project Team Performance Monitoring
- Identify, assign, monitor and provide guidance and input into the completion of interdisciplinary project tasks which may include but not limited to GXP assessments, computer system validation strategies and deliverables, system risk assessments, and data privacy impact assessments. Ensure task completion and performance meets or exceeds quality standards and client, project and regulatory guidelines.
- Provide team and project performance feedback to system owners, product line owners and/or department managers when necessary.
Project Documents and Tools
- Lead the planning and creation or revision of Quality System policies and procedures for use with computer systems and impacted processes.
- Ensure effective training is planned, developed and delivered in accordance with project timelines.
- Manage the appropriate creation, delivery, maintenance of project related data, documents, equipment and tools.
- Develop new/or improved project approaches, documents, guidelines and tools in response to project retrospectives and/or changes in regulatory or industry guidelines.
Vendor Management and Stakeholder Support
- Organize and provide input into vendor negotiations for new system purchases, changes in scope or timelines to existing systems and communications with both internal and external stakeholders.
- Act as the primary liaison throughout the project life cycle ensuring internal and external stakeholder and/or vendor expectations are appropriately managed, addressing and resolving issues, planning and executing all project meetings, assisting with strategies and materials, and providing regular project status reports.
- Monitor vendors and partners to ensure they are meeting agreed upon timelines, contractual obligations, deliverables and escalate issues/concerns when necessary.
Information Security Frameworks
- Plan and execute the creation and/or updating of information security framework documents, including applicable Quality System documents, and controls (e.g. ISO 27001 and SOC 2) to ensure compliance with industry standards.
- Prepare and participate in internal and external surveillance and recertification audits, coordinate the collection of evidence and work with internal teams to address applicable compliance gaps.
Third-Party Risk Management
- Plan and execute the collection of third-party risk assessments for Alimentiv IT vendors.
- Analyze vendor responses to determine adequacy of controls and work with vendors to address identified gaps.
- Collaborate with vendor managers to ensure consistency in third-party risk mitigation controls across the organization.
Qualifications
- The successful candidate should have a Bachelor's degree with a minimum of 4-6 years of related experience + Project Management Institute (PMI) - PMP (PMBOK) certification completed.
- Strong written and verbal communication skills
- Proficient with MS Office products
- Experience with Project Management Software (e.g. MS Project, Smartsheet)
- Highly effective interpersonal, facilitation, organization and influence skills and capabilities
- Proactive; detail oriented; critical thinking; task driven
- Experience in Life Sciences an asset
- Experience in vendor negotiation an asset
Working Conditions
- Home-based
What We Do
From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.