Experience

Medclin Research

• India
• Hospitals and Health Care
• 1 - 100 Employee

• Clinical Researcher

  • Jun 2021 - Present



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr. Project Management Analyst

  • Jan 2014 - Nov 2021

  Assess use of Sponsor systems and include in Project Plan as needed Develop Clinical Operations Plan (COP) and Study-specific documents including Monitoring Plan, SDV Plan and Study Reference Manual / guidelines to Sites Develop and provide guidelines for Site Initiation Visit as per POD guidelines Develop Investigational Product Handling Guidelines (as appropriate) Develop Data Delivery / Monitoring strategy. Provide guidelines & monitoring Tools for Interim monitoring visits Provide functional documents to defined storage locations / repositories Customize Project-specific document collection lists. Create document repository guidelines and archive Plan independently Show less



KlinEra Global Services

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Project Lead

  • Jun 2018 - Jan 2019

• Clinical Project Lead

  • Jun 2018 - Jan 2019



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead CRA

  • Aug 2008 - Dec 2013

  Study monitoring, Investigator Training, Site Selection, Initiation and Closure. Ensuring Studies are conducted as per the GCP, Regulatory and Protocol compliance Tracking study updates and progress, Project Management, Inventory management, Budget Forecasting and communicating Study updates to designated CPL. Attending global teleconferences to provide study updates and concerns to global project leads Leading Core Project team and cross unit coordination with finance, supply chain etc and external parties (vendors) to meet overall Project targets and establish contingency plans for key resources Ensure study team training as per protocol and amendments on an ongoing basis. Coordinating with study team members in India for all study related issues. Ensuring training record compliance with training matrix and records are up to date. Provide training to new CRAs during co-monitoring Adhering to global tools for monitoring and forecasting. Ensuring regular update of global tracking tools-application and Team communication on the requirement of the same Identify and escalate GCP issues identified through regular interactions with CPL/PM Show less



SIRO Clinpharm Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Research Associate

  • Feb 2007 - Aug 2008

  Site selection, Initiation and monitoring visits according to ICH-GCP guidelines. Report Submission and Publishing with timely follow ups Ensuring Site staffs are well trained with Protocol and Systems (IMPACT, OCRDC and Phase forward EDC tools) for smooth Study conduct. Ensuring Site conforms to study without deviating from Protocol, GCP and applicable guidelines with special emphasis on subject safety, Investigational product and subject consent Escalation of issues to CSM in a timely manner. Follow up with site on regular basis for any issues related to the study, finance, reporting of SAEs Following sponsor SOPs and tools for good conduct of the study. Conduct of site level feasibilities. Coordinate between site and sponsor proper information flow. Study on Major Indications: For Sponsor Companies (Pfizer, Novartis, MSD, Peregrine and Boehringer Ingelheim)  Diabetics Peripheral Neuropathy-DPN (Phase II)  Ophthalmology (Phase IV)  Oncology: Glaoblastoma Multiform (Brain Tumor) (Phase III)  COPD (Phase III)  Asthma (Phase III)  Psychiatric (Bipolar maniac) (Phase III) Show less



Syngene International Limited

• India
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • Sep 2006 - Jan 2007

   Site selection, Initiation, Monitoring and Close-out  Follow up with sites for Ethics Committee approvals and other essential documentation  Data verification and Safety tracking  Coordination with sites and sponsor for easy conduct of the study  Providing Weekly updates to Sponsor  Site selection, Initiation, Monitoring and Close-out  Follow up with sites for Ethics Committee approvals and other essential documentation  Data verification and Safety tracking  Coordination with sites and sponsor for easy conduct of the study  Providing Weekly updates to Sponsor