Akanksha Chauthmal

Dedicated professional with a proactive approach and rapid learning ability. Demonstrates strong work ethic and effective communication skills. Committed to contributing to team success and achieving organizational objectives.

• Experience in the pharmaceutical industry and medical writing
• Knowledge of regulatory documents and ICH-GCP guidelines
• Proof reading, quality control and copy editing experience
• Advanced word processing skills
• Expertise in word for windows, including creation and adaption of document templates
• Knowledge of Adobe Acrobat and document formatting standards

• Date of Birth: 09/28/91
• Gender: Female

Phase III trial to evaluate the efficacy and safety of live attenuated Bovine-Human Rotavirus re-assortant pentavalent Vaccine (BRV-PV) sponsored by Serum institute of India, Limited Phase III, observer blind, randomized, multi-country, non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicals’ quadrivalent seasonal influenza candidate vaccine Phase II study- NASH, GSK, Astrazeneca Phase III study, Ulcerative colitis, Polpharma Phase II Study, HCV and Hepatic Encephalopathy, Bausch Pharmaceuticals

• NIH- Online- 'Protecting Human Research Participant'
• Online- Collaborative Institutional Training Initiative (CITI) Training
• Sense CR- Writing Effective SOPs; Key to Quality and Compliance
• GlaxoSmithKline- ICH GCP training
• Investigator outreach meeting (ICH-GCP)
• Ethical Dilemmas in Healthcare Services held at Health Management studies and Research, Pune
• Workshop on DNA Isolation held at L.A.D College, Nagpur
• Analysis of Health Profile of employees and students of Symbiosis International University, 12/01/13, 03/31/14

• Provide support to Global GSK sponsored and supported R & D Trials across all therapeutic area
• Organize study start up teleconferences with study team, if required
• Assist in study start up activities and ensure compliance for the drug shipment as per GSK process
• Update and maintain the data with accuracy and integrity within all relevant GSK study systems
• Supporting GSK Clinical Study team to meet urgent deliverables ensuring inspection readiness
• Assist the study teams in the close out activities to ensure compliance to requirement and effective study closure
• Compilation and generation of Clinical Study Report Modular Appendices (i.e LOI and SAT)
• Manage and Archive essential documents as per GSK Sponsor TMF SOF
• Ensure the process KPI defined are met for the study
• Organize and participate in all appropriate meetings with GSK & TCS
• Recording and maintaining training information as per iTRACT SOP and applicable requirement