Archana Tammara

• Defining, running, and reviewing edit checks and resolving discrepant data. • Maintaining organized, complete, and up-to-date study documentation. • Creating or reviewing transmittal forms for a study, ensuring consistency with existing standards. • Keeping supervisor informed of project status. • Reviewing data and identifying errors/inconsistencies. • Developing study data specifications, including data transfer specifications, system configuration specifications, and data validations.

• Develops, Implements, Administers and maintain procedures for ensuring the security & Integrity of the Data Base. • Resolving data base performance and data quality issues. • Enter newly executed projects into Data Base. • Use contract, internal budget, and protocol documents to obtain project details. • Update records as needed by contract status changes.

• Assist the Project Leader in requesting access for team members for Project Portal, Data Base and P-MED as required. • Assist Project Specialist and Project Analyst with associated tasks such as development of Communication Plan, Study Status, data collection and study specific document preparation. • Distribute PMED links of all study documents and material to study team upon request of the PL and COL and request signature pages, where required.

• Assisted in patient recruitment & retention for long term follow up in the study. • Maintain effective and ongoing communication with sponsor, research participants and PI during the study. • Resolution of queries, safety reports & study status report. • Storage, reconciliation & ordering of IP through IRT system. • Identify & assist in SAE/AE reporting & documentation.

• Tracking & confirmation of drug receipt in IVRS & IWRS system Subject Randomization in IVRS & IWRS system (Perceptive). • Identify & assist in SAE/AE reporting & documentation. • Coordinate in CRF data generation, e-CRF filling based on Source Documents. • Resolving data queries, Communicate with Central Lab, Central Pharmacy, Courier. Maintenance & filling of Site Master File. • Communicate with EC for Study related submission. • Reported patient safety status (PSUR).

Drug Development and Discovery, Clinical Research, Data Management, Drug Safety and Pharmacovigilance, Ethical and Legal issues of Drug development, Regulatory Affairs, Marketing and Sales.

Clinical Research, Regulatory Affairs, Clinical Data Management & SAS Base

Pharmaceutics, Pharmacology, Clinical Pharmacology, Medicinal Chemistry, Pathology, Pharmacognosy, Phyto - chemistry.