***, ******** *******, **/*, Shivajinagar, Pune- 411005, Maharashtra, India
** ***** ** ******** ******** including 05 years of managerial experience. A team-focused personality with multi-tasking orientation, efficient communication skills and good learning curve. Enjoys challenges and remains dedicated towards goals/objectives of the organization.
Clinical Trial Design and Strategies
Regulatory requirements for generic & 505b2 approvals, mainly USFDA
Phase I to IV experience- end to end study activities
Clinical Data management
Clinical End-point studies
Experience (Key points are enlisted below)
2017 – UNTIL NOW
Research Scientist, Head- Clinical Endpoint and Manger- Clinical Data Manager/ Lupin Bioresearch Center, Pune
Lead all clinical endpoint studies
Identify new CROs for conduct of clinical studies
Identify vendors for software to handle data management activities
Lead data management team and perform training for them
Participated in preparing data management Standard Operating Procedures
Handled audit for data management activities and clinical end point studies and provided satisfactory responses to clear the observations
Successfully executed all assigned projects including one oncology study- performed all operational and project management activities for this study success and received USFDA approval for this product
Involved in four inhalation PK studies as Physician, device trainer, project management activities and also lead all data management activities for these studies
Worked with Medidata for data management activities
Lead training and development activities and review the presentations of entire clinical research staff and arrange it once in a month for all staff for knowledge share
Act as a network leader for Lupin’s Women Network group and involve in various activities
2014 – 2017
Research Scientist, Manager- Clinical Endpoint / Lupin Bioresearch Center, Pune
Complete project management, vendor management and clinical development responsibilities for all clinical endpoint studies.
Lead all the clinical endpoint studies, right from the inception to final deliverables.
Single point of contact, both internal and external, for all clinical endpoint studies.
Lupin contact for CROs/vendors on RFP, study feasibility, study conduct strategies, study initiation to completion and study finances.
Support internal teams, mainly R&D and Regulatory, from product pipeline development to regulatory submissions.
2011 – 2014
Associate Scientist, Associate Manager- Clinical Endpoint / Lupin Bioresearch Center, Pune
Preparation and review of protocol, ICF, CRF and other study plans for clinical endpoint studies
Project management for all in-house projects and also work with CROs project management teams to review and track the activities for all outsourced studies
Performed all bid defense activities for studies of derma, ophthalmic, oncology etc.
Perform site qualification, monitoring visits to Investigators site and CROs
Provided clinical inputs to statistician to calculate the sample size for all the proposed studies
Provided training to Investigator site as well as project management team on protocol and other study requirements
2008 – 2011
Research Associate, Clinical Endpoint / Lupin Bioresearch Center,
A key role in preparation of SOPs such as project feasibility assessment, vendor selection & qualification, site visits & monitoring etc.
Compiled and reviewed all the clinical study documents
Coordinated with different CROs (India, US, Europe etc.) for getting cost estimates for pipe line projects
Accessement of CROs by reviewing their capabilities and therapeutic experience to initiate the vendor identification and selection procedure
Literature, draft OGD review etc.for various pipeline projects to provide clinical inputs
2006 – 2008
Clinical Trial Coordinator / Bharathi Vidyapeeth Medical Hospital & Research Center, Pune
Worked as a coordinator for National and International pediatric clinical trials (especially vaccine trials) and also coordinated Institutional Ethics committee and scientific Advisory committee meetings at Bharati Vidyapeeth’s Medical Hospital
2001 – 2006
Private Medical Practice / Pune
Also worked in Gynecology and Obstetrics hospital for 2 years and assisted all the related activities
MBA (Masters in Business Administration) / Yashwantrao Chavan Open University, Nashik
CRCDM (Post Graduate Certificate Course in Clinical Research and Clinical Data Management) / Pune University, Pune
Medical Transcription / Indian Transcription Group, Pune
BAMS (Bachelor of Ayurvedic Medicine and Surgery) / Bharathi Vidyapeeth Ayurveda College, Pune
Therapeutic Indication/Areas worked
Obstetrics & Gynaecology
Awards and Achievements
USFDA approval for oncology product with no observation, 2019
Presented on Clinical supply management topic in Cold chain Management workshop held by Parenteral Drug Association in Apr 2018
Act as a best inhalation device trainer for inhalation studies, 2016 - 2019
Presentation given in GCP training workshop in 2017 and 2018 conducted by Lupin Bioresearch Center
Lupin’s ESOP received in 2015
USFDA approval for 04 derma corticosteroid products with no observations, 2016
‘Bravo award’ for the passion of excellence, 2014
Conducted Lupin’s first sleep study on an innovative drug, 2013
Winner of ‘Change maker contest’, to recognize the contribution in work related activities, 2012
Best contribution award, Rifaximin clinical trial, 2011
Active member of Lupin Women Network’s team, 2011-until now
Active participation in ‘Joy of Giving’ activity, 2008- until now
Would like to work in product development area to provide clinical inputs and strategies to move ahead for study conduct and product approval.
To provide clinical inputs to the clinical study from its inception to completion.
To handle clinical operations, clinical data management and project management activities of clinical studies
Also, would like to support or play a crucial role in other activities like selecting CROs, involve in bid defense process.
To lead all clinical trial activities from initial phase to final stage
Available on request