Shreeram Das

Responsible for leading activities of Clinical Data Management from start-up to close out. Cross functionally working with different team members to get the project deliverables. Reporting to Sponsor, study team and internal management with all kinds of study related updates. Mentoring juniors and collogue for Clinical Data Management activities. Preparing timelines, budgets and looking for project utilization.

Responsible for handling a DM team as a project manager and getting activities accomplished in given timelines meeting sponsor, CBCC standards in accordance to given SOPs and given timelines. Cross functionally working with sponsors, internal CBCC team, vendors and other applicable team for DataManagement related activities. Timely provides an updates to sponsor and internal project team during meetings. Responsible for training and mentoring for applicable team members with respect to Data Management

Performed study operational activities i.e. query management, data review, data reconciliations. Created study specific metrics i.e. Quality and TAT, maintained Operational Issue Log. Responsible for the oversight of data cleaning for allocated studies which includes query count and study status. Drafted Clinical Data Management operation documents: Data Management Plan, eCRF completeness guidelines (CCG), Data Review Guidelines, Validation/ testing plan and Data Transfer Agreements specifications.

Performed eCRF Screen review based on the protocol requirements or specification provided that is interpretation of protocol against eCRF designed. Drafted Data Management documents: DMP, CCG, Data Review Guidelines and Data Transfer Agreement/ Specifications. Performed Clinical Data Review, Query Management, SAE Reconciliation, and Vendor Data Reconciliation. Responsible to create study specific metrics i.e. Quality and TAT. Performed all activity associated to Database lock, Decommission and Archiving.