Ing. Sravan Kumar Akabilvam

• Responsible and accountable for managing all end to end Data analysis activities and deliverables. • Identify the trends in the data and possible solutions for efficiencies. • Performed study startup activities including reviewing protocols and writing edit check specifications, test validation and derived procedures, eCRF completion guidelines, data handling plan (DHP), third party data handling guidelines, User Acceptance Testing (UAT) plan and presentations for Investigator Meetings.

• Understand the data management requirements of the clinical trial protocol in order to perform Data analysis tasks. • Performed all third-party Data Reconciliations (Central Labs, ECG, PK-Pharmacokinetic data, PD-Protocol deviation data) • Performed SAE reconciliation using Safety database (ARGUS) and Clinical database and regular follow up with associates of Safety database, preparation of Safety Data Amendment Request Form (SDARFs), Maintaining SAE Tracking Sheet.

• Provide basic and some comprehensive data management expertise to the data management team to provide efficient, quality data management products that meet customer needs. • Performance of all data management tasks including query management, listing review and third party lab reconciliation. • Perform basic quality control procedures with guidance from DOC or Functional Manager.

Pharmaceutics, Pharmaceutical Sciences, Statistics, Computer science, Advanced Drug Delivery systems, Pharmaceutical Analysis, Biopharmaceutics

Pharmaceutical Sciences, Statistics, Computer science, Pharmacology, Biopharmaceutics, Pharmacokinetics, Pharmacodynamics, Drug Delivery systems, Pharmaceutical Jurisprudence