Dr Narayanam R

Around 7+ years of experience in Clinical Data Management delivering Data Review and Management objectives in various clinical studies and phases in a timely manner. Extensive experience in working with Phase I through Phase III of clinical trials using EDC. Experience in working on various EDC databases including Medidata Rave, Oracle Clinical (RDC) and Inform. Developed and maintained Data Management Plans (DMP) which was implemented throughout the project life cycle. Working experience in developing Data Transfer Agreements (DTA) with external vendors. Communicated and coordinated with different global teams in various studies. Extensive knowledge in different phases of the clinical data management including study start up, study conduct and study lock. Extensive experience in Protocol Reviews, creating Study Design, Edit Checks, Query Logics, Test cases, QC and User Acceptance Testing (UAT). Reviewed eCRF data worked with CRO in designing the CRF’s and clinical database. Support clinical trials for CRO by providing accurate data. Involved in SAE reconciliation and LAB reconciliation, worked with external CRO. Worked extensively during study conduct on validating the data, cleaning the data, Discrepancy management. Overlooked set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF). Oversees and ensures the CROs and Third-Party Vendors are in alignment and are delivering per the scope of work. Worked extensively on study closing activities including Data Review, Data freezing and Study Lock. Assisted in performing clinical data interim analysis. Worked on compliance checking of data review guidelines in accordance with the regulatory guidelines. Involved in the audit process of the data management with the sponsors. Knowledge in Medical Coding with MedDRA and WHO Drug. Thorough knowledge in Database QC, CRF tracking and Database Auditing. Sound knowledge on ICH-GCP and 21 CFR Part 11 guidelines. Good verbal, written, interpersonal and communication skill.

• Postgraduate research on Regenerative Dental Medicine University of Michigan(Ann arbor)
• Advanced ICH GCP Certification (AGCPC)
• National Board Dental Examinations
• Advanced Dental Admission Test
• Dental Implants
• Laser Dentistry
• Restorative Dentistry
• CDA certified- DANB
• Blood borne pathogens certification (American Academy)
• Certificate in Intra-oral radiography (MI)
• CPR (American Heart Association)
• Infection control knowledge pertaining to OSHA and HIPAA

American Cancer Association -2018

Greater New York Dental Conference-2018

Indian Dental Association Conference-2009

City dental camp – 2008 MEMBERSHIP

Member of Indian Dental Association (IDA)

Member of Andhra Pradesh State Dental Council (APSDC)

• Dentistry
• Oncology
• Cardiology
• Hematology
• Immunology
• Neurology

• BIOCOMPATIBILITY ASSESSMENT OF OZONATED OLIVE OIL AND COMMON IRRIGATING AGENTS IN REGENERATIVE ENDODONTICS
  1Lalitha Sravani Kanumalla, 2Ramyasaketha Narayanam, 3Chandrabhatla Srinivas Kumar and 3Jayalakshmi Pandranki
• ANTIMICROBIAL SILK FIBROIN METHACRYLATED SCAFFOLDS FOR REGENERATIVE ENDODONTICS
  Ramyasaketha Narayanam, Lais M. Cardoso, Caroline Anselmi,
  Ana Beatriz G. de Carvalho, Sahar Aminmansour, Sepideh Aminmansour,Abdel H. Mahmoud, J. Christopher Fenno,Maedeh Rahimnejad, Renan Dal-Fabbro, Marco C. Bottino (manuscript submitted from University of Michigan)