Prakruthi D J Email and Phone Number

- Understand and interpret clinical trial study protocols to design and develop calendars and coverage analysis.- Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol.- Design and develop case report forms for clinical trial study protocols.- Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.- Maintain high level quality and customer SLAs for all services.- Provide input in process development and improvement. - Assist in developing internal and customer-faced documentation.- Independently troubleshot customer reported issues.- Train fellow team members. Work closely with the reporting manager to complete daily/ weekly. - calendars, budgets, financials and/or case report forms are designed to meet with pre-determined quality criteria.- Participate in customer interactions over the e-mail/telephonically to assimilate customer requirements and address those adequately in all services.- Assist in managing teamwork/workload distribution by understanding and utilizing internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed.- Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols.

- Design and develop case report forms for clinical trial study protocols. Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.- Understanding and utilizing the internal case management software and other reporting software to ensure that daily/weekly work are appropriately tracked and completed.-Active participation in team meetings and contributing meaningfully to discussions related to specific customer cases and/or protocols.

1. Preparation and reviewing of Pharmacy manual for handling of Investigational products involved in the Clinical trials (Phase I to IV)2. Handling of Investigational products (Injectables, Tablets, capsules), management of Investigational products inventory.3. Performing UAT of the EDC database involved in the Clinical Trials.4. Hands on experience in RAVE Medidata and RTSM.5. Handled Investigational products of about 100 Clinical BA/BE studies and Complex Clinical Trials (Phase I to Phase IV).