Prabha Sri Padmanabhan

• Managing Clinical Study as POC and Manage comprehensive data management tasks.
• Involved in preparation of Data Quality Checks Specification, Database Specification, eCRF Completion Guidelines .
• Performed User Acceptance Testing (UAT) for RAVE .
• Under guidance created , reviewed and sign-off on all data management plan (DMP) documents.
• Provide guidance and training to entry Level associates and colleagues as well as new hires.
• Involved in Internal Quality Review of queries and listings for global studies.
• Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes.
• Served as the escalation point for unresolved data issues; with guidance, worked with client data managers, vendors, and internal team members for resolution.
• Demonstrate/describe data review processes to sponsors and auditors as and when needed.
• Managed a team of 5 Professional Data management staff across various studies.
• Ensured project milestones are pertaining to Data Management Function and meet according to agree upon timelines with high quality.
• Interacted actively with various cross functional team professional growth.

• Involved in Conduct and Close-out activities.
• Clinical DM Activities- Query Management, Vendor Reconciliations , Safety Recon with review of Issue Logs, SAS listings ,Data set Qc, Custom Report Validation,Performing Metrics, data entry, Validation, creating Testing Comments Log and Test Plans,Documentation of files as per TMF filing guide lines and maintaining eTMF (ELVIS) .
• Participated In DOC skill space training and handled 3 Projects
• Mentoring of new joiners along with project members.

Activities performed on Paper study

• Lead a team of 40 members on QC of DCF .
• Actioning of, multivariate and Univariate queries, sending DCF's to site on Weekly basis. Data entry for CRF's and DCF's
• Track and follow up on missing CRF through PIMWEB

• Sound Knowledge of Medical Terminology, anatomy and Physiology
• Medical Transcription, ICD-9 ,10 CM, CPT, HSCPS and HCC coding.