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Study Start-Up Leader

Parexel International Corporation

India, Remote

The Associate Study Start-up Leader/ Study Start-Up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC/IRB submissions, SIV scheduling and activation requirements.

Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.
Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC/ IRB Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
Collaborate and communicate within the Global study team matrixto provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities.

Participate in client meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics.
Partner closely with both Functional Leaders and Local Site Managers to proactively identify study start up related issues
Develop and execute corrective actionsto mitigate risks to activation timelines
Ensure that relevant - systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level).
Deliver and maintain client-focused reporting to measure performance and proactively identify issues for resolution