Manohar K

About Manohar K

A strong clinical background as B.Pharmacy graduate with 11 years of clinical research (CRO) experience.Experience and knowledge in Data management.Trained on ICH- GCP guidelines and regulatory requirements. Key skills include- 1.Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues. 2.Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly 3.Assist with development and documentation of external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly. 4.Support development of the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable. 5.Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database. Train new staff and mentoring.

Experience

1. Senior Lab Data Specalist

   Novotech

   Apr 2022 — Present · Bengaluru, IN

   Lab Data specialist

Education

• KLE College of Pharmacy, Bangalore

  Bachelor of Pharmacy - BPharm, Pharmacy, First

  2006 — 2010

• Avigna Clinical Research Institute

  PG diploma in clinical research, Clinical research, First

  2011 — 2011