Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Vennela Mogili

Manchester

Summary

I have over 6+ years of experience in Clinical Trial Operations and TMF Support for Phase1,2 and 3 clinical trials. And 3 years of experience as a Clinical Biochemist in Medical College, INDIA. Oversaw quality reporting from biochemical laboratories, implementing rigorous quality control measures to ensure accuracy and reliability of results. Collaborated with laboratory staff to standardize renal stone analysis and iron binding capacity using various methods, contributing to improved research methodologies. Conducted regular audits and inspections to maintain compliance with industry regulations and internal quality standards. Implemented corrective actions and process improvements based on quality metrics and feedback. Managed day-to-day operations of biochemical laboratories, emphasizing adherence to standard operating procedures (SOPs) and regulatory requirements. Spearheaded the standardization of renal stone analysis procedures, resulting in increased efficiency and consistency in laboratory processes. Facilitated training programs for laboratory technicians to enhance their skills and ensure compliance with established protocols. Collaborated with the research team to design and implement experiments related to iron binding capacity, contributing valuable insights to ongoing projects.

Overview

8
8
years of professional experience
1
1
Certification

Work History

TMF Specialist

Zenith Life Sciences
05.2020 - Current
  • Processing, filing and tracking in Accordance with Study specific TMF plan
  • Perform TMF QC and remediation across functional lines
  • Maintain complete and accurate study documents as per SOPs, GCPs and ICH Guidelines
  • Strong knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology
  • Conducting training and meetings with project teams
  • Ensures that each document is finalized only when it meets all the quality and compliance criteria per project specific guidelines
  • Responsible for ensuring study documentation is in a final state for migration purposes and conducting query resolution with appropriate personnel.

Research Biochemist

Government Medical college
06.2016 - 03.2019
  • Ensured Quality Reporting from Biochemical Laboratories
  • Working with Research Team (Standardization of Renal stone Analysis, Iron Binding Capacity with different Methods).

Education

Bachelor’s in pharmacy -

Bapatla college of pharmacy

Master’s in health informatics -

New England College

Skills

  • SOP Implementation
  • Regulatory document review
  • Ability to interact professionally with external customers
  • Client focused approach to work with the ability to interact professionally within a client organization
  • Strong ability to influence and negotiate resolutions and outcomes with sites
  • Client focused approach to work; ability to interact professionally with external customers Strong ability to influence and negotiate resolutions and outcomes with sites
  • Knowledge of clinical trails activities
  • Electronic data capture(EDC),Metadata,eTMF,CTMS,TMF
  • Software-Veeva Vault,Metadata,Master control
  • Clinical Trails
  • Analytical skills
  • Microsoft Office (Word,Excel, Power Point and MS project
  • Project management skills
  • ER MDR Remediation
  • GCP/ICH Guidelines Competency

Certification

  • Trainer for National conference-cum-workshop on animal pharmacology and toxicology studies.
  • Participated in National webinar on (IPAT-2021) entitled relevance of intellectual property rights to pharmacy research and applications of biostatics in pharmacy research.
  • Thesis: Anti-Arthritic activity of piperine loaded novel dosage form.
  • Thesis: A new simple accurate and economical reverse phase High Performance Liquid Chromatographic method was developed for the determination of Esomeprazole in pellet dosage form and validated in terms of ICH guidelines.



Timeline

TMF Specialist

Zenith Life Sciences
05.2020 - Current

Research Biochemist

Government Medical college
06.2016 - 03.2019

Bachelor’s in pharmacy -

Bapatla college of pharmacy

Master’s in health informatics -

New England College
Vennela Mogili