Collin Rivera, PMP

• Supported enterprise conversion from MS Project to Planisware. • Overhauled the Clinical Studies Timeline Template to improve usability, reduce rework, and strengthen schedule governance (baseline, variance, and change control). • Developed and maintained study and medical writing deliverable templates to improve quality, consistency, and on-time delivery across studies. • Developed and implemented Phase IV non-site timeline template; improved planning consistency for operationally complex, non-site activities. • Led enterprise, cross-functional initiative to redesign the Planning Phase of the study template to reduce startup time and clarify handoffs, dependencies, and deliverables; resulted in establishing standardized durations for study startup. • Mentored and onboarded new clinical planners. • Manage multiple concurrent clinical projects; own project scope, schedule, and execution for clinical planning deliverables. • Develop and maintain integrated clinical study schedules (medium to high complexity) in MS Project using standard templates; define scope, sequence, dependencies, and milestone owners. • Create baselines and perform variance analysis; lead risk identification/mitigation and proactive issue escalation to protect key milestones. • Conduct “what-if” analyses and manage critical path from study start through First Patient First Visit (FPFV) in partnership with Clinical Operations and functional stakeholders.

• Built detailed, cross-functional submission timelines for IND, BLA, and EMA deliverables; aligned milestones, owners, and dependencies to support readiness. • Created executive-ready program overviews (OnePager) to communicate timeline, scope, and critical path to leadership. • Facilitated cross-functional Submission Task Force meetings; drove action-item closure, managed risks/issues, and escalated timeline threats.

• Owned R&D benchmarking and performance metrics (protocol amendments, KPIs, dashboards) to improve visibility and decision-making across program portfolios, portfolios of clinical projects, and study teams. • Automated and maintained project dashboards, status reporting, and portfolio tracking for all clinical study portfolios, reducing quarterly effort from 40+ hours to 2–3 hours; improved timeliness and data quality for leadership reporting. • Provided global operational support that drove device studies to 100% CTMS compliance within 6 months, exceeding a 90% corporate goal. • Led global, cross-functional initiatives (Regulatory, Clinical Ops, Quality, Manufacturing, Product Surveillance, EHS, Trade/Compliance) including building a clinical quality system (SOPs and Work Instructions), clinical quality system harmonization, creating Quality Agreements, and compliant clinical shipping/explant processes. • Created a work instruction documenting a standard approach to managing a Phase I study as a clinical project planner. • Supported study finance and forecasting (budget tracking, accrual tools); created automation to reduce cycle time and improve variance management. Executed Class III post-market device studies along with Phase III pharmaceutical studies. Project-managed timelines for Phase I–IV pharmaceutical studies. Managed day-to-day operational aspects and performed timely issue resolution.