Raghunandan S

About Raghunandan S

Good working knowledge of ICH-GCP, Schedule - Y, USFDA, CDISC Standards, GCDMP and various other regulatory requirements in clinical research.My Primary interest lies with Discrepancy Management in Clinical Data Management. Good working experience in Clinical Operations: Literature reviews of Protocol, ICFs, IB, SOP’S and CRF for Clinical Trials. Team Management Role:• Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development.• Ensure that new associates has the proper materials, systems access and training to complete job Responsibilities• Assist in ensuring consistent standardized processes are implemented and department deliverables meet expected quality and productivity targets.• Provide suggestions to management and lead process initiatives. Clinical Data Management Role: • UAT• Listing validation• Review data, particularly edit checks that have fired, and identify trends and discuss with the clinical team.• Utilize logic and reasoning to identify edit checks that aren\'t working.• Pinnacle 21 report• Prompt Monitoring and DET• Discrepancy Management (Including Clinical Queries and CRA Queries)• Co-ordinate with assigned discrepancy management team to ensure data quality throughout the study duration. • Manual Listings • Lab, IVRS and SAE Reconciliation• Pulling Reports from Tools• File Management activities• Preparing and sending the Data status Report.• DB Cleaning activities• Ensuring PI signature is obtained for all the CRF(s).• Executes all Data Science processes involved in the locking of the trial database for assigned trials• Maintenance of PRISM.• Ensure study documentation is up to date throughout the study and submitted eTMF as appropriate.• Accountable for all data management related activities of a study• Conduct Trainings for new Associates and Act as Mentor for new joiners.• Work allocation to the study team, maintain the TAT and measure the quality.• Arranging internal and client study meetings on a regular basis and maintaining the MOM.• Assisting Team Lead by collating Leave details, Progmet tracker and PM metrics report etc.Specialties: Discrepancy Management, Data Validation and External data ReconciliationExpertise in Oracle Clinical (4.6 Version) and Phase Forward.Trained on ICH-GCP & e-systems (IVRS, IWRS, EDC and CTMS).

Experience

1. Data Team Lead

   IQVIA

   Mar 2023 — Present

Education

• Sri Venkateswara University

  B.Sc, Biochemistry, Chemistry, Microbiology

  2002 — 2005

• Sri Krishnadevaraya University

  M.Sc, Biochemistry

  2005 — 2007