Key Accountabilities:

Organizational Relationships

Reports to Director or Senior Director of Start-Up Project Management, or Group LeadCollaborates with global study managers, study operations managers, site care partners, site activation partners, investigator contract leads, feasibility specialists, clinical trial assistants, study team leads, operations planners, and process leads

Project Management

Partner with country and site feasibility specialists to integrate current intelligence into startup strategy and site activation plansCoordinate with teams responsible for regulatory submissions and startup functions to align country and site activitiesContinuously assess workload across SUPMs to anticipate needs and adjust team assignments accordinglyOversee progress of study-specific and country-specific tasks required for site activation (e.g., vendor setup, IP supply, regulatory submissions)Lead project management activities to ensure timely completion of site activationsFacilitate startup meetings to align site selection and activation activities with trial optimization plansCollaborate with country-level startup roles to identify opportunities to accelerate site activations while balancing priorities across concurrent studies

Plan Delivery

Accountable for the quality and completeness of startup timeline plans at study, country, and site levels within the enterprise project management (EPM) systemCreate and manage baseline and snapshot timelines to track site activation targetsEnsure consistent participant compensation across studies to avoid cross-study impactIntegrate protocol amendments into activation plans and manage site green-lighting post-activationResponsible for site activation timelines from initial investigator package to final site activationUnderstand and manage critical path activities for each site, including:Timely delivery of investigator initiation packagesCoordination with budget and contract specialists to remove delaysOversight of site readiness tasks (system access, training)Planning delivery of investigational and non-clinical supplies

Risk Mitigation

Coordinate across study teams to assess site readiness and proactively identify and mitigate risksServe as escalation point for site activation issues raised by country-level startup rolesResolve issues directly or triage to appropriate team members, ensuring follow-through

Process Improvement

Identify efficiencies and improvements in site activation processesShare lessons learned with key stakeholders to enhance future performance

Compliance with Parexel Standards

Complete required training curriculumSubmit accurate timesheets and expense reportsMaintain updated CVAdhere to Parexel processes, ICH-GCP guidelines, and other applicable regulations

Skills and Competencies

Experience in country or regional startup across at least two major therapeutic areasTechnical proficiency in clinical study management software and reporting toolsAbility to apply basic generative AI techniques in daily workSkilled in risk management methodologyFluent in written and spoken English

Knowledge and Experience

Extensive global experience in clinical trial startup and study managementStrong working knowledge of Good Clinical Practices, monitoring, and regulatory operationsDeep understanding of clinical trial methodologyPreferred experience includes:Demonstrated startup project managementProven project management capabilities

Education

A scientific or technical degree is preferredMust have a BS/BA – 5 years relevant experienceMS/PhD – 3 years relevant experience
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