Talented Manager bringing a record of success in spearheading Clinical studies and operations day-to-day management. Performance-oriented, driven and creative with good program pitching and organizational skills. Diplomatic in resolving conflicts and building consensus between operational areas.
Establish overall performance standards for projects, project managers and their teams.
Assign project managers, team members or other staff to various tasks or phases of work in the life cycle of multiple projects or products.
Supervise project managers and the training and work of production, design and also development staff.
Track performance of members of various project teams or groups to assess compliance with budgetary, time and other requirements.
Purchase or request or work with project managers to purchase or request needed supplies, equipment or services within budgets or limits set by upper-level management or the organization.
Review work product of teams for compliance with organizational objectives and goals.
Report progress of work, goals, problems and other issues to supervisors, upper-level management or boards of directors or committees responsible for oversight. Review news, regulations and updates related to the organization's products, services or programs.
Formulate and implement plans for recovery, alteration of work or otherwise handling emergencies, disruptions of programs, production or project schedules and unanticipated events
Works with CRO to develop and revise study specific plans, bid defense plans, detailed timelines, and ensure that performance expectations are met.
Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
Participates in the development, review and implementation of departmental SOPs and processes.
Manages the study project plan, including timelines and budget.
Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
Reviews site study documents (informed consent template and study tools/ worksheets.
Managing and coordinating cross-functional project teams
Serving as the primary project contact with the Sponsor
Monitoring team performance against contract, customer expectations, and project baselines
Leading problem solving and resolution efforts to include management of risk, contingencies and issue resolution
Developing study management plans, together with team assignments and accountabilities and oversight of database maintenance
Ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Executed proof of concept implementations to validate product feasibility
Designed, engineered and supported various IT projects
Spearheaded all major migration projects for 100 county offices, spanning desktop to ThinkPad and operating systems migrations, achieving on-time completion with 100% budget adherence.
Obtained project specifications for security products.
Enhanced development and drove continuous improvement of project delivery process by providing strong program leadership.
Managed multiple project teams engaged in software implementation in cross-functional environment to reach project success.
Applied extensive expertise in System Development Lifecycle (SDLC) methodologies and Agile project management techniques to manage multiple project teams.
Oversaw budgets for project, tracked expenses and timelines and communicated with key stakeholders on milestones.
Compiled information from departments on operations, reducing time and complexity through proper planning.
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