Deepika Khedekar

Experience

• 

  Pfizer

  May 2010 - Jun 2010

  Intern in Quality Assurance Department

  *Pfizer is one of the world’s largest research-based, global biopharmaceutical company that enables research, development, and commercialization of medications for diverse range of health conditions including heart problems, cancer, rare diseases, immune disorders, inflammation, and diabetes. *Acquired hands-on experience in wet chemistry analysis, including calibration of analytical balances, pH measurement, weight variation, disintegration, and dissolution tests using specialized apparatus.*Developed proficiency in research and development, performing qualitative and quantitative analysis of drug moieties using TLC, Gas Chromatography, and HPLC, while also gaining knowledge in microbiology laboratory practices for pathogen detection and ensuring product safety. Show less

• 

  Cognizant

  Apr 2014 - Jan 2015

  Clinical Data Analyst

  *Cognizant is a global technology consulting company, offering services to some of the world's largest enterprises spanning the healthcare, financial services, media and communications, and consumer products industries.*Developed and implemented a robust end-to-end clinical data management framework for a pivotal Phase 2 Clinical Trial, orchestrating seamless study operations, fortifying data integrity, maximizing data reliability, and fostering synergistic collaboration, thereby safeguarding the study’s credibility, minimizing risks and accelerating study timeline. Show less

• 

  Aim Research Services Pvt Ltd

  Jun 2015 - Dec 2015

  Clinical Research Assistant

  *Led 3 pivotal clinical trials for a leading skincare company in Bangalore, India, driving accelerated product development efforts and market expansion.*Developed and implemented a comprehensive 5-pillar clinical trial resiliency framework, encompassing protocol development & adherence, data integrity, patient safety, regulatory compliance, and stakeholder management, resulting in optimized trial operations and robust outcomes.*Mentored and supervised 2 Junior Clinical Research Associates (CRAs), ensuring successful enrollment and engagement of 50 patients per clinical study throughout the entire study lifecycle. Show less

• 

  KlinEra Global Services

  Jan 2016 - Aug 2020

  *KlinEra provides innovative clinical trial and research services across multiple therapeutic areas to some of the largest global pharmaceutical companies.*Led and successfully managed a portfolio of 4 clinical trials in diverse therapeutic areas of Rheumatoid Arthritis, Ulcerative Colitis, and Crohn’s Disease over a period of 4.8 years, enabling sponsors to expand their research across 30+ healthcare sites in India.*Secured critical regulatory approvals from DGCI (eqv. Of FDA in India), enabling the launch of studies in India and expanding research initiatives, while also providing valuable insights during peer reviews for DGCI submissions.*Streamlined contract and budget negotiations between clients and hospitals, fostering productive partnerships, optimizing financial efficiency, and mitigating budgetary risks for clinical trials.*Provided mentorship and supervision to a team of 5 Junior Clinical Trial Assistants (CTAs), fostering their professional growth and ensuring efficient study execution. Show less

  • Clinical Research Associate

    Apr 2017 - Aug 2020

  • Clinical Trial Assistant

    Jan 2016 - Mar 2017
• 

  MACLEODS PHARMACEUTICALS LTD.

  Aug 2020 - Jul 2021

  Clinical Research Associate

  *Led a Phase 3 clinical study on Respiratory Bronchitis, benefiting over 80 patients in 18 hospitals across India, resulting in the successful completion of the trial within the predetermined timeline and budget, while ensuring regulatory compliance and data integrity.*Implemented an innovative clinical operations framework, prioritizing patient well-being, streamlining ethical considerations, ensuring data integrity, and accelerating research timelines, leading to successful regulatory approval of the trial results. Show less

• 

  IQVIA

  Jul 2021 - now

  Associate Centralized Clinical Lead

  *IQVIA is one of the largest Clinical Research Organizations in the world, operating in over 100 countries and providing advanced clinical research services to global pharmaceutical companies. *Led Clinical Trial Risk Analysis Program across 9 pivotal trials conducted in US and Australia, ensuring protocol adherence, compliance with regulatory standards, high-degree of data integrity and reliability, and prioritizing subject safety. *Served as an advisor to Clinical Trial Managers (CTMs), streamlining reporting processes for Clinical Research Associates (CRAs) through the development of visit report annotations and guidelines, leading to enhanced study efficiency.*Recognized with the Impact Award for making a significant contribution to the company in 2022. Show less