Serves as primary operational contact for Study/Functional level.
Exhibits strong project management and organizational skills to monitor study progress and manages Line management responsibilities of reporting PDMs.
Effectively leads team of PDMs assigned to the protocol, demonstrating strong interpersonal and people management skills,
Own proven team building skills and ability to foster partnerships across projects. Communicate effectively via oral and written communication skills to influence, inform or guide others
Exhibits strong knowledge in Oncology clinical trials and provide mentoring support to assist PDMs. Accountable for data management start up, lock or database update activities. Oversee all studies assigned to reporting PDMs and suggest resolutions for the issues highlighted by PDMs independently
Accountable to ensure that the issues noted during data management which impact the overall timelines are addressed, informed to client and coordinate follow-up on the mitigation plans. Engage client to assist in the resolution of more complex issues
Ensure that data management activities follow global and Program level standard requirements, study timelines, ICH-GCP guidelines, Client SOPs and regulatory guidelines or regulations
Work with other cross functional Accenture Team Leads for effective and timely resource allocations.
As applicable and required, attend study team meetings with PDM to provide oversight support during study start up meetings as needed. Provide leadership inputs as and when needed during regular meetings with internal and external stakeholders responsible for the assigned study
Effectively uses available tools to gather information needed to manage study activities, track study execution activities against the schedules defined and generate reports to review regular updates entire life cycle of the project
Follow appropriate escalation pathway to inform internal as well as external stakeholders of problems and potential solutions
Process studies, if required
Accountable for completion of all database lock activities of the reporting PDMs to the standards expected
Attend all applicable study lock meetings for any assistance to PDM
Understands the importance of data quality and uses this to drive all data management review to lock related activities daily basis
Contributes to the establishment and/or development of best practices and ensures best practices are shared to key stakeholders to support consistency within a program
Ensure PDMs deliver study activities/timelines to client within the set timelines and per quality expectations for the process