The PMO Project Manager manages assigned projects or workstreams within established PMO standards and governance, ensuring they are planned, monitored, communicated, and delivered with discipline and consistency.
Project management at Sitero is the application of standardized processes, tools, and leadership practices to guide cross-functional teams in delivering projects from Initiation through Closure. It ensures alignment to scope, schedule, cost, quality, compliance, and stakeholder expectations while managing risks, dependencies, and changes throughout the project lifecycle across one or more of Sitero’s eClinical platforms (e.g., EDC, RTSM, CTMS) or contracted services (e.g., Clinical Operations, Data Management). Sitero’s Project Life Cycle (PLC) phases are Initiation → Planning → Execution (Implementation) → Monitoring & Controlling (Maintenance) → Closure. “Client” refers to the contracting organization, which may be a study sponsor, a contract research organization (CRO), or another organization such as a technology vendor or partner.
Project Planning & Lifecycle Management
- Manage projects or workstreams through all phases of the Project Life Cycle (PLC), from Initiation through Closure, within defined scope, schedule, and budget.
- Manage multiple concurrent client engagements, balancing priorities, timelines, and resources across studies, projects, and services.
- Lead the sales-to-delivery handoff for assigned clients, partnering with Business Development and the PMO Program Director; review the Statement of Work (SOW), scope, timelines, financial terms, and risk profile.
- Set up the project in enterprise systems (e.g., Rocketlane, ServiceNow) and complete required administrative setup during the Initiation phase.
- Establish realistic high-level timelines during the Initiation phase and baseline them during Planning to support requirements management and client expectations.
- Develop and maintain integrated project plans, including milestones, dependencies, resource allocations, and risk, issue, and action logs.
- Review timelines routinely with the project team and client to keep delivery tasks (configuration, documentation, testing, delivery, maintenance, and close-out) on schedule.
- Manage formal change control, including scope change requests, impact assessments, and forecast updates.
- Track and report project KPIs, health, and budget performance; escalate risks, issues, and dependencies to the PMO Program Director to support timely decisions.
- Coordinate quality events, audits, interim analyses, database locks, and compliance activities as applicable.
- Coordinate the Closure phase, including client acceptance, final deliverables, system decommissioning, resource release, financial close-out, archival per QA and regulatory requirements, and lessons learned.
PMO Governance & Standards
- Provide regular reporting to clients, PMO leadership, and delivery stakeholders.
- Apply PMO standards, templates, and reporting practices consistently across assigned work.
- Meet PMO Service Level Agreements (SLAs) on assigned projects; escalate SLA risks to the PMO Program Director.
Client & Stakeholder Management
- Serve as primary point of contact for the client and internal stakeholders on assigned projects; lead internal and external meetings.
- Manage client expectations, proactively communicating risks, scope changes, and delivery updates.
- Prepare and distribute agendas, minutes, action logs, status reports, change requests, and client communications promptly; track follow-up actions.
- Manage escalated client issues through resolution, in coordination with Support; route complex escalations to the PMO Program Director.
- Lead post-implementation client training and manage client product version upgrades.
- Represent client requirements to Development during product delivery.
- Monitor client satisfaction, adoption, and early risk signals on assigned projects; support CSAT/NPS collection; and report concerns to the PMO Program Director.
- Identify upsell, expansion, and service enhancement opportunities and share them with the PMO Program Director and Business Development.
Application & Technical Support
- Maintain sufficient knowledge of Sitero’s eClinical platforms (EDC, RTSM, CTMS, eConsent, Payments) to support clients and facilitate discussions with product SMEs.
- Engage SMEs early in each phase to ensure requirements and scope are complete.
- Work with Implementation, Programming, Quality Control, Data Management, Support, and Training teams to resolve project issues.
- Support product deployment, build testing, and validation of outputs (e.g., reports, data listings) as required by project scope.
- Support development of project documentation (e.g., source documents, completion guidelines, user guides) as required by project scope.
Quality & Compliance
- Adhere to all organizational SOPs and work instructions; apply PMO quality standards on assigned projects.
- Create, maintain, and version-control project documentation, ensuring it is accurate, current, and stored in controlled repositories per PMO standards and SOPs, consistent with GCP, 21 CFR Part 11, and client requirements, so it remains inspection-ready.
- Provide input to SOP reviews related to project management.
- Prepare for and participate in internal and external audits and inspections; contribute to audit and inspection response documentation and related quality investigations.
- Complete assigned CAPA and deviation actions on time and contribute to root cause analysis.
- Maintain strict confidentiality of blinded and unblinded data in all communications.
- Handle personal and protected data in accordance with SOPs and applicable data privacy requirements (e.g., EU GDPR).
Organizational & Professional Contribution
- Share knowledge and support onboarding and knowledge transfer for new team members.
- Provide oversight of projects owned by PMO Associate Project Managers as assigned, and share performance input with the PMO Program Director.
- Propose workflow improvements that increase team efficiency and client service quality.
- Collaborate with internal staff to resolve project issues; escalate when appropriate.
- Participate in company-sponsored training, product demos, and release update meetings relevant to the role.
- Maintain current knowledge of industry trends, standards, regulatory requirements, tools, and eClinical technology.
- Perform other duties as assigned.
Success Measures
- Assigned projects are well planned, well controlled, and clearly communicated.
- Project documentation, logs, and reporting remain current and reliable.
- Risks, issues, and changes are tracked consistently and addressed promptly.
- Stakeholders experience organized, proactive project coordination.
- Client satisfaction on assigned projects is maintained or improved, and at-risk signals are raised early.
- PMO standards are applied consistently across assigned work.
