Project Manager

Qualification

● 7+ years of project/program management experience, including large, complex enterprise implementations with multiple workstreams.
● Demonstrated experience delivering pharmacovigilance or drug safety programs (process and/or systems) is highly desirable.
● Hands-on experience using Clarity for project planning, resourcing, and/or financial tracking.
● Proven ability to manage vendor-led delivery and multi-stakeholder governance.
● Strong track record with RAID, integrated planning, dependency management, and executive reporting.

JD:

Program & delivery leadership
● Develop and maintain the integrated program plan, schedule, RAID log, resource plan, and delivery cadence.
● Drive cross-workstream execution (e.g., business process, configuration/build, integrations, data migration, reporting/analytics, validation, training/change, and operations readiness).
● Manage dependencies across internal teams and external vendors; remove blockers and escalate effectively.
Governance & stakeholder management
● Establish governance structure, meeting rhythm, decision logs, and escalation pathways.
● Prepare and facilitate steering committee and project leadership meetings; ensure decisions are documented and followed through.
● Communicate clearly with executive sponsors, PV leadership, IT, QA, and vendor stakeholders; tailor messaging to audience.
Planning & control (Clarity + standard PM practices)
● Use Clarity (and supporting tools such as MS Project, Jira/ADO, Confluence/SharePoint as applicable) to:
○ Build and manage the work breakdown structure (WBS), milestones, and baselines
○ Track time, capacity, resource allocations, and financials where required
○ Produce status dashboards, schedule variance, and forecast reporting
● Define project standards for status reporting, change control, and document management.
● Manage project finances.
Risk, issue, and change management
● Own the RAID process: identify, quantify, mitigate, and monitor risks; drive issue resolution.
● Lead scope and change control: impact assessment (timeline/cost/quality/compliance), approvals, and baseline updates.
Quality, compliance, and validation support
● Partner with Compliance team to align delivery with GxP regulated expectations:
○ Ensure required deliverables, reviews, and approvals occur on schedule
○ Maintain traceability from requirements to testing and release readiness
○ Support audit/inspection readiness through disciplined documentation and evidence collection
Readiness, cutover, and hypercare
● Coordinate training, SOP/process updates, communications, and adoption tracking.
● Lead cutover planning, go/no-go criteria, and hypercare transition to steady-state support.