Sai Kumar

Overall 9.4 + years of experience in Clinical Research with Graduation in B-Pharmacy and certified in advanced program in clinical research and clinical data management.

Currently, working as STUDY START-UP SPECIALIST-II (Regulatory Document Specialist II) at IQVIA, Bengaluru from Dec-2018 to present.

• Previously worked as ‘Records Management Associate –II’ with 3 years 5 months at PAREXEL International (India) Pvt Ltd from 21-June-2015 to 30-Nov-2018 and have good knowledge in PMED eTMF System, Datalabs utility Tool system by handling multi-tasking process - eTMF documentation, PMED eTMF Tool analyst and eCRF pdfs Archive global SME.
• Worked as Clinical Research Coordinator at ‘Asian Institute of Gastroenterology, Hyderabad from 18-Dec-2013 to 20-June-2015 with work experience of 1 year 6 months.

Pharmacy Graduate with 4 months training in Clinical Research, Clinical Data Management, Pharmacovigilance at CLINI-INDIA, Hyderabad.

• performing Debarment checks for Investigators and reviewing Essential documents of Green light package for IP release to site.
• Managing trackers and assigning requests to team.

Create Central Files for new studies and maintain Central Files for ongoing studies according to PAREXEL SOP’s or contractual obligation to sponsor

• Upload, apply naming convention and file Central Files documents in electronic document management system as required for project team members
• Support retrieval of documents
• Enter clinical trials data into the appropriate database, if required
• Photocopy, print and distribute documents, as needed
• Ensure up to date study documents in tracking systems / document repositories
• Coordinate flow of incoming and outgoing documents with project team members
• Maintain quality control procedures, including periodic basic quality, inventory and completeness checks to ensure accurate maintenance of files
• Make necessary arrangements for internal and external audits
• Perform archive procedures upon study termination: prepare copies of Central Files as required by Sponsor and PAREXEL Internal Records
• Prioritize completion of tasks according to projects’ needs and deadlines

Overall 9.4 + years of experience in Clinical Research with Graduation in B-Pharmacy and certified in advanced program in clinical research and clinical data management.

Currently, working as STUDY START-UP SPECIALIST-II (Regulatory Document Specialist II) at IQVIA, Bengaluru from Dec-2018 to present.

• Previously worked as ‘Records Management Associate –II’ with 3 years 5 months at PAREXEL International (India) Pvt Ltd from 21-June-2015 to 30-Nov-2018 and have good knowledge in PMED eTMF System, Datalabs utility Tool system by handling multi-tasking process - eTMF documentation, PMED eTMF Tool analyst and eCRF pdfs Archive global SME.
• Worked as Clinical Research Coordinator at ‘Asian Institute of Gastroenterology, Hyderabad from 18-Dec-2013 to 20-June-2015 with work experience of 1 year 6 months.
• performing Debarment checks for Investigators and reviewing Essential documents of Green light package for IP release to site.
• Managing trackers and assigning requests to team.

Create Central Files for new studies and maintain Central Files for ongoing studies according to PAREXEL SOP’s or contractual obligation to sponsor

• Coordinate flow of incoming and outgoing documents with project team members
• Maintain quality control procedures, including periodic basic quality, inventory and completeness checks to ensure accurate maintenance of files
• Make necessary arrangements for internal and external audits
• Perform archive procedures upon study termination: prepare copies of Central Files as required by Sponsor and PAREXEL Internal Records
• Prioritize completion of tasks according to projects’ needs and deadlines

Pharmacy Graduate with 4 months training in Clinical Research, Clinical Data Management, Pharmacovigilance at CLINI-INDIA, Hyderabad.