Project evaluations and assessment of results; Implement and manage project changes andinterventions to achieve project outputs. Present reports defining project progress,problems, and solutions. Constantly monitor and report on progress of the project to allstakeholders. Provide direction and support to project team. Track Project deliverables usingappropriate tools. Develop and Manage Risk Mitigation Strategies for projects. Plan andschedule project timelines. Manage project budget. Develop full scale cross-functionalproject plans. Define project tasks and resource requirements. Facilitate the definition ofproject scope, goals, and deliverables. Lead the planning and implementation of cross-functional project(s).

Lead and participate in Risk Based Management Meetings; Attend and provides support inclient-facing meetings including bid defenses. Participates in the presentation of internalproject status reviews and assists with action item follow up. Assists with the identificationof risks and issues through review of project process and metrics. Contributes to thedevelopment, maintenance and approval of project plans and support functional team leadsin trouble-shooting and contingency planning. Supports cross-functional team leaders andthird parties/vendors. Prepare and assists with reporting on project metrics, finance, statusof deliverables and risks/issues with the associated management plan. Mentored junior levelstaff and served as a resource for new employees.

Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company andsponsor SOPs, project plan, study-specific processes, local regulatory requirements. Acts asprimary site contact/liaison for study and site management issues including addressingquestions, inclusive of protocol questions, managing study supplies and conducting offsitecentral monitoring visits/contacts (pre-study, initiation, monitoring and close out visits).Escalates issues and risks, as needed. Performs risk assessments and managementresponsibilities throughout the project including site process evaluation, addressing followup items and issue escalation. Completes essential document collection and reviewthroughout the study lifecycle, organizes and maintains site clinical trial master file (TMF)documents, and maintains site-related data in applicable clinical systems according toprocedures and guidelines. Performs data review inclusive of site level data review, queryresolution, facilitates database closure and freezing procedures as per study plans. Worked inpartnership with hiring managers, providing guidance, support, and recommendations forprospective candidates.

Liaises with internal and external stakeholders to meet project specific goals; Prepares forand participates in Investigator and Client meetings as necessary, escalate project and siterelated issues per PRA SOPs, ensures client and investigator obligations are being met andare compliant with local regulatory requirements and ICH-GCP guidelines. Performs projecttracking to ensure clinical and site management information, including but not limited toproject files, site contacts, client communications, and training assignments are current,accurate, complete, and audit ready. Manages additional clinical operations and projectmanagement tasks as required and outlined in job task list. Owns activation and managementof assigned sites to ensure adherence to protocol design and proactively coordinates anddrives completion of all requirements with urgency and professionalism includingcoordinating all process contributions, escalating status and risks with mitigation plans,leveraging tools and dashboards to monitor timelines and quality of activation critical path,and meeting high quality documentation requirements.

Recruits and evaluates potential sites for project participation, utilizing assessment tools andquestionnaires to obtain project required information. Manages additional clinical operationsand project management tasks, as required, and outlined in job task list. Performs essentialdocument collection, review, maintenance, submission, notification, and close-out activities,including but not limited to informed consent form (ICF) template(s), ensuring client andinvestigator obligations are being met and are in compliance with applicable local regulatoryrequirements, ICH/GCP guidelines, and PRA SOPs.

Uses the learning management system to assign project-specific training to team membersand tracks training compliance. Supports Project Manager with financial related tasks. Hasoversight of purchase order process including creating and processing purchase orders andstudy invoices. Organized study information and supplies, including generating andmaintaining organizing charts, team calendars, newsletters, mass mailings, contact lists, studywebsites. Tracks, dispatches, and maintains study supplies following applicable companyprocesses. Organizes project team and client meetings including scheduling, meetingmaterials, binders, agendas, and meeting minutes.

Provided assistance to claim handlers by performing a variety of services including setting up claim files, entering electronic claim information, and receiving/distributing incoming mail. Performed receptionist duties as assigned. Efficient in Microsoft Office Software.