Global Trials Optimization Specialist – Project Manager I

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Collect data, benchmarks, and modeling inputs to aid in feasibility and trial optimization planning.

• Facilitate the development of program reviews, content evaluations, and the escalation of requirements.

• Schedule timelines for validation, deliverable creation, stakeholder alignment, presentations, and country validation requests.

• Assist with validation and Clinical Trials Allocation Committee activities, including scenario planning, risk table inputs, validation reviews, modeling updates, and final allocation requests.

• Write the initial Global Trials Optimization Report and maintain updates throughout the trial lifecycle.

• Conduct recruitment needs assessments and ensure trial-level GTO reports are current and actionable.

• Lead early planning for recruitment and retention during the feasibility stage.

• Create recruitment needs assessments and estimates for program-level recruitment budgets.

• Submit requests to vendors and prepare recruitment and retention strategies.

• Collaborate with legal on concept evaluations, vendor proposal assessments, scopes of work, and material or tactic reviews.

• Ensure effective implementation of recruitment and retention plans, as well as enrollment support materials.

• Oversee the development of enrollment support materials and execution of tactics.

• Provide materials to the Metrics, Analytics & Performance team for Study Optimizer plan entry.

• Request and manage system updates as trial requirements evolve.

• Identify enrollment challenges, evaluate risks, and suggest mitigations with study teams.

• Manage routine enrollment support materials and vendor activities.

• Monitor enrollment performance and generate standard reports.

• Analyze performance trends and pinpoint opportunities for improved support.

• Coordinate enhanced enrollment support, including rescue site and country activities, recruitment and retention meetings, participant- or site-facing materials, rescue vendor engagement, advocacy engagement, and community outreach.

⛳️ Requirements

• Experience in supporting clinical trials, feasibility assessments, recruitment planning, enrollment strategy, or trial optimization.

• Strong capability to gather, interpret, and utilize data for planning and decision-making.

• Proficient in coordinating timelines, deliverables, stakeholder reviews, and cross-functional contributions.

• Ability to collaborate with clinical trial teams, vendors, legal, analytics, and other business partners.

• Excellent written communication skills for developing reports, plans, updates, and study-facing materials.

• Detail-oriented with the ability to manage multiple priorities in a fast-paced clinical research setting.

• Oncology clinical trial experience, particularly in lung or breast cancer studies, is highly preferred.

• Prior experience as an oncology site coordinator is highly preferred.

• Familiarity with recruitment and retention vendors, enrollment support materials, or patient/site-facing recruitment strategies is highly preferred.

• Knowledge of enrollment monitoring, performance analysis, country validation, risk tables, or trial allocation processes is highly preferred.

🏝️ Benefits

• Career development and progression opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a total rewards program.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• Company match for 401(k) contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions or bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick time provisions.

• Reasonable accommodations provided when appropriate.