Associate Director, Clinical Project professionals

• 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. • Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.• Define project workloads and assignments. Develop and oversee maintenance of databases and project plans.• Collaborate with other functional groups within the company wherever necessary to support milestone achievement and to manage study issues and obstacles.• Provide status updates, risks, protocol deviations of projects at internal and sponsor meetings.• Lead problem solving and resolution efforts to include management of risks, contingencies and issues. Develop proactive contingency plans to mitigate clinical risks.• Report performance of projects against the project baselines – schedule, cost, etc and initiate change order if required and track the performance against the new CO baselines.• Implement continuous improvement activities for the assigned projects.

• Manage execution of the assigned medium to large globally based clinical studies from initiation through to closeout.• Ensure that all clinical study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.• Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement.• Establish and maintain a project monitoring, control and reporting system that supports on-going assessment of project performance and facilitates informed and timely adjustment of project execution to achieve project objectives • Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate project risks.• Report team performance against contract, customer expectations, and project baselines to management• Implement continuous improvement activities for the assigned projects.

From May 2003 worked in Accenture Services Pvt. Ltd, Bangalore and have handled different roles and responsibilities for different sponsors within a span of around 12 years such as Data Operations Manager, Process Lead, Team Lead, Certified trainer, mentor, etc.• Oversee the data cleaning operations for all studies/protocols transitioned to Accenture by sponsors and ensure all study/protocol activities are completed according to Data Management Plan.• Oversee and manage Quality Control team leads and SMEs for studies assigned to Accenture team by sponsors.• Responsible to meet all sponsor SLAs and adherence to Management Operating System to communicate progress, challenges, success to respective stakeholders per project plan.• Project management, resource allocation, cross training, calibration, risk management and mitigation planning.• Ensure timely and accurate reporting of study status, defect information and metrics to stake holders.• Ensure people are compliant with sponsor SOPs, WIs, trainings and adhere to Good Clinical Practices.• Provide leadership and do performance management of counselees and their respective teams• Drive continuous process improvement initiatives and add value to process, people and organization.