SHILPA Pantula

• Result-driven professional with over 14 years of experience in engagements covering Line Management, Project Management, Training & Mentoring and Site Management.
• Strong project management skills with excellence in ensuring all projects are delivered within the agreed scope, time, cost and quality;
• Handled 7 clinical trials of national importance. Managed team of 35 project staff .Successfully completed 3 trials
• Conduct of Phase II and III trials where successfully
• Enrolled maximum of 1800 participants in one of the ICMR sponsored Phase III trial.
• Handled project planning, implementation, and support for clinical systems project. Led and managed project development from inception to completion .
• Recruited, hired and trained all staff, providing direct supervision, ongoing staff development and continuing education to team members.
• Communicated with patients, ensuring that medical information was kept private.
• Proved successful working within tight deadlines and fast-paced atmosphere.
• Identified issues, analyzed information and provided solutions to problems.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Used coordination and planning skills to achieve results according to schedule.
• Worked flexible hours across night, weekend and holiday shifts.
• Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Skilled in formulating budgets, SOPs & policies, designing systems & processes and work instruction to ensure smooth process; ensured adherence to ICH/GCP guidelines, defined SOPs, site compliances, EDC.
• Improved operations through consistent hard work and dedication.

• Lead, monitor and delegate daily trial activities and collection of case report forms using eCRF
  Trial management using Web-Based Clinical Trial Management System .
   Experience in Liaising with Doctors on Conducting Trail
   Coordination with Ethics Committee.
   Management of Informed Consent Process (document development, approval, translations).
   Overseeing trial budget
   Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan.
   Maintaining Trial Master File
   Maintain records and other documentation of training.
   Ensure strict adherence to quality principles in all aspects of the trial
   Coordinate and facilitate monitoring and auditing visits.
   Notify appropriate institutional officials of external audits.
   Apprise all stakeholders including sponsors, CRO and regulatory bodies regarding the routine progress about the trial.
   Successfully completed two ICMR sponsored projects

• Catering to laboratories and medical institutes conducting organ transplantations. July 17-Till date Bhagwan Mahaveer Medical and Research Center, Hyderabad as Site Manager for Clinical trials
  Apr 2016 – June 2017 Biogenuix Medsystems Pvt Ltd, New Delhi Senior Manager, Pan India Operations
  • Providing training, troubleshooting and technical support to personnel involved in performing transplantation diagnostics like PCR based HLA typing (SSP, SSOP, SBT and LUMINEX), cross-match, lymphocyte profiling (Flow cytometry based) etc.
  • Providing training, troubleshooting and technical support to personnel involved in Prenatal diagnostics using QF-PCR.
  • Provide necessary steps for executing training of paramedical staff for organ transplant monitoring and sample collection.
  • Training of laboratory technicians to perform various molecular and immunological pre and post-transplant tests for assessing graft compatibility and rejections.
  • Coordinating with various Hospitals across India for promoting molecular biology based HLA testing methods and highlighting their merits by conducting short presentations on HLA immunogenetics

• Development of Real Time PCR methods for quantitation of Measles, Mumps and Rubella virus titers in monovalent and multivalent combinations.
• Mammalian cell culture, virus culture.
• Viral vaccine manufacturing. Stability studies of viral vaccine batches.

• Catering to laboratories and medical institutes conducting organ transplantations.
  • Providing training, troubleshooting and technical support to personnel involved in performing transplantation diagnostics like PCR based HLA typing (SSP, SSOP and LUMINEX), cross-match, lymphocyte profiling (Flow cytometry based) etc.
• Provide necessary steps for executing training of paramedical staff for organ transplant monitoring and sample collection.
  • Training of laboratory technicians to perform various molecular and immunological pre and post-transplant tests for assessing graft compatibility and rejections.
  • Coordinating with various Hospitals across India for promoting molecular biology based HLA testing methods and highlighting their merits by conducting short presentations on HLA immunogenetics.