A well experienced professional with over 13+ years of experience in Research & Development, Knowledge Management and Project Management
Sr. Clinical Process Specialist
Quintiles March 2016 - at PresentSupport CL to develop Clinical Operations Plan (COP) using DTE-specific template, and study-specific documents, including: Monitoring Plan, SDV Plan and Study Reference, Manual/Guidelines/Instruction, annotated Site visit report and letter templates, scripts for remote monitoring visits and telephone contacts as applicable; Coordination with PDT for development of Various tools, templates, plans and training material; Request site monitor resources for site selection visits. Verifies training compliance and system access for the site management team involved during the study start-up; Verifies that all Helplines/toll free numbers have been requested and activated as per scope by each operational lead as appropriate (e.g. Helpdesk lead (EDC), PCC lead (PCC involvement) or QCC); Support CL to Develop and provide (e) CRF Completion Guidelines
RSCP College of Pharmacy June 2012 - at PresentIn RSCP as Principal for UG and PG students along with the regular activities of running the academic setup I was also responsible for the research planning and the regularization of research based publications of the PG students. Guidance to research was the major task at RSCP
Dr. VPPC College of Pharmacy August 2009 - at PresentDuring my days with Dr. VPPC college, I was mainly responsible as Principal for planning and executing the various academic programs, examinations and monitor the quality of education delivered to the students. Educating the students with personality development was my responsibility. I arranged various training programs and on site training as well for students for the better understanding of what they learn theoretically in class rooms.
VedDoc CRO Aurangabad November 2006 - at PresentDuring my experience with VedDoc, I got involved in clinical trials belonging to two major therapeutic areas, Seasonal Fungal Infection, mental depression and diabetes. The study on the patients with fungal infection was Phase II study (dose determination) for the sponsors from overseas and depression and diabetes studies were for Indian MOH submission. The two studies on diabetic patients were Phase 1B and Phase III. All the three studies were multi centric and conducted across the Nation. I had been involved in the protocol development, study documentation development, investigator selection, feasibility assessment, budget negotiation with the investigators, ethics committee submission, planning the clinical trial material procurement (study specific), planning the monitors visit at the site, continuous coordination with the sponsors, dealing with the regulatory affairs department, maintaining the study files etc.
Sr. Project Coordinator
Synchron Research services Pvt Ltd June 2004 - at PresentSOP preparation and reviews for the project management department, Drafting and Reviewing Clinical Study Protocol. All Bioequivalence and bioavailability studies and Phase 1B, II and III clinical trial protocol development, getting the inputs from the expertise both in house and sponsors’, getting the protocol QA audit done and resolving the audit issues, if any, were the major responsibilities; Submission of Investigator’s Package to Ethics committee. Submission of the protocol and the study related essential documents (CRF / ICF), planning the IRB, incorporate the IRB recommendations, communicating the IRB decisions to the stake holders were the major responsibilities; Planning the Project.
Accutest Research Pvt Ltd June 2002 - at PresentIn Accutest as a Sr. Project Coordinator, I had been responsible for the overall project management for the BA BE studies. Overlooking the projects and completing the different project tasks such as drafting the study protocol, ethics submission, CRF, ICF and other essential study document designing, announcing the project, maintaining the essential study files, communication with the stake holders, updating the stakeholders about the study proceedings and mile stones, monitoring the in house studies, making the draft and the final reports, were the major responsibilities.
Om Sai Clinical Research Pvt Ltd August 2013 - February 2016Responsible for the Clinical Quality Assurance functions of the organization reporting to the MD. Ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted at OSCR. Lead a team focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, along with OSCR policies and procedures for the conduct of clinical trials. This involves working closely with Clinical and analytical Operations, Information Technology, stat and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities