Venkata Sai Sri Charan Akella

• Responsible for the execution of key Central monitoring (Site, subject & study level review as applicable) activities, and assisting in the execution of several key activities and lead certain activities within the study,.
• Conduct risk review assessments reviewing the Risk indicators/metrics of the applicable for each study and communicate the findings at the country, study, site, subject level to the team for actions to mitigate the risks.
• Lead the team meetings with the Trial Leads to assess the Key risks of region and sites for attention.
• UAT verification of the data being integrated in the Informatics platform on a monthly basis.

Therapeutic Experience: COPD, COVID studies

Phases of Study: Phase III & Phase IV

• Assistance in Informed Consent Process, Patient selection and Recruitment.
• Under supervision, perform assigned administrative tasks to support team members with project execution.
• Maintaining the source documents, CRF’s, Investigator Site File and other study related documents according to ICH-GCP guideline.
• Assist the pharmacist in drug accountability and temperature maintaining logs.
• Coordinating with the local labs, central labs.
• Completing the review forms and submitting deviations documented to EC.
• Responsible for the CRF, e-CRF entry, Data Query resolution.

• Supporting Business Development and Sales Team by addressing complex requests of company's trial/therapeutic experience, as assigned by management
• Review and analyze requests to ensure appropriate clinical experience related information is shared
• Co-ordinate with appropriate medics/subject matter experts in cleaning clinical experience data
• Follow up with appropriate teams for additional information as required
• Updating company's clinical experience data repository
• Supporting continuous maintenance and enhancements to company's clinical experience data by using all tools available (e.g., internal databases, external libraries) to complete missing and correct/adjust existing information
• Assisting in preparing internal and client-ready presentations of company therapeutic experience.

• Performing centralized monitoring activities on assigned projects and evaluate the quality and integrity of study data as per protocol, SOPs respective regulation and guidelines.
• Perform Subject Level data review that require further investigation with clinical site to determine overall accuracy.
• Conducting Periodic review of site level KRIs and historic site performance according to Centralized monitoring plan(Risk Based Monitoring using data driven trial execution).
• Monitoring site performance and make recommendations for timely corrective action (E.g. Site telephone contact or Triggered Onsite monitoring visit).
• • Early identification and mitigation of site level risks occurring during study conduct

Therapeutic Experience: Hyperlipidemia.

Phase: Phase III

• Perform quality assurance checks on radiographic and photographic medical imaging data to ensure protocol specific requirements are met
• Perform established image processing techniques (converting imaging formats, performing preliminary measurements of lesions and volumes) across multiple modalities (including but not limited to CT, MRI, Bone Scan, X-Ray) using proprietary software as well as other third party software
• Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project specific protocols
• Act as liaison with investigator site personnel to resolve issues that arise over the course of the clinical trial

Promotion and Achievements:

• Promoted from IRA to IRA II in a span of one and half year for exhibiting quality work
• Got recognized for High Performance Culture

Imaging Knowledge: HRCT, CT, MRI, X-Ray-Chest, Bone Scans

Therapeutic Experience: Oncology, Lung Fibrosis

Phases of Study: Phase II & III

• Train pharmaceutical professionals on Bacterial Endotoxin Testing (Gel clot, Turbid metric and Kinetic methods) and PTS (Endosafe product)
• Certifying the Quality department in Pharma companies for Bacterial Endotoxin Testing (BET)
• Indirect sales of Endosafe and Accugenix services.

Wetlab Experience: Label claim certification, routine testing and Validation of the new APIs and products.

• Being the head of the department for biology, taking care of the lesson plans and worksheets of the other teachers in the department
• Taking responsibility of the class allotted and updating student's status
• Handling biology lessons for high school students (VIII
• IX & X classes)
• Accomplishments: Was awarded the best teacher for the month of

• Manpower management for the production activities in Emulsion section and Paint section
• Executing shift wise planning of Emulsion batches in accordance to paint house plan
• Ensure the 100% efficiency output in the activity deployed and reverting to the maintenance issues if any with the concerned department
• Raw material planning of Emulsion and Paint batches for next two shifts
• Carrying out DCS operations in the shift
• System entries of the production details (in SAP)
• Daily emulsion reports generation and circulation to peers
• Project: Xylene vs Reactor hygiene studies Kaizen project.