• Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout. • Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift. • Independently develop integrated study management plans with the core project team. • Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards. • Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget. • Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs. • Managing risks proactively and leading problem solving and resolution efforts • Support the development and maintenance clinical SOPs & trial process’ as required. • Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach. • Management of complex multi-national, multi-center clinical research projects • Develop patient recruitment strategies • Conduct contract and budget negotiations with sites and vendors • Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders • Train study team members and act as mentor for CPMs • Work independently with limited supervision • Attend medical conferences and represent clinical operations through investigator engagement and/or presentations