Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. -Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. -Implement continuous improvement activities for assigned projects.-Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.-Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.-Report on team performance against contract, customer expectations, and project baselines to management.-Lead problem solving and resolution efforts to include management of risk, contingencies and issues. -Develop proactive contingency plans to mitigate clinical risk.-Identify quality issues within the study and implement appropriate corrective action plans. -Escalate findings and action plans to appropriate parties.-Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.-Provide input for the development of proposals for new work and project budgets.-Provide input to line managers of their project team members’ performance relative to project tasks. -Recommend team members’ further professional development. -Support staff development. -Mentor less team members-Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.-Prepare and present project information at internal and external meetings.-Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.-Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans

Management of project activities and project team members.Focal point for communication between sponsor and Quintiles.Responsible for managing timelines, quality and costs of projects deliverables. Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect information on team performance against contract, customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provide input and manage project budgets.Prepare and present project information at internal and external meetings.Participate in proposal development and in the bid-defense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of the CRA team.

Participated in protocol, Case Report Form (CRF), and Informed Consent design as needed.Served as Project Manager or Clinical Project Leader for multi-operational projects.Provided high level technical and/or therapeutic expertise to clinical staff on project start-up, coordination, and management.Responsible for independent coordination, and management of study start-up, and clinical monitoring activities for large, complex protocols and/or international programs.Responsible for managing investigator contract and budget.Assured adherence to Good Clinical Practices (GCPs), by both investigational sites and clinical monitoring staff.Participated in the mentorship and training of Lead Clinical Research Associates.Provided training and consultation related to clinical study initiation and ongoing operating activities in the conduct of Phase II through Phase III clinical trial projects.Participated in review and update of new SOPs.