Dr. Sudha Rani Thimmiri

• Having 3+ years of experience working in the field of Clinical Data Management delivering Data Review and Management objectives in various clinical studies and phases in a timely manner.
• Worked on multiple projects simultaneously with taking little to no guidance from the project managers.
• Extensive experience in working with Phase I through Phase III of clinical trials.
• Experience in working on various EDC databases including OCPRD, Clinbase & Basic knowledge of Rave and Data Labs
• Worked predominantly on data analysis and data governance.
• Communicated and coordinated with different global teams in various studies.
• Extensive knowledge in different phases of the clinical data management including study start up, study conduct and study lock.
• Worked extensively during study start up on CRF designing providing study specific and protocol specific guidelines.
• Provided and assisted in creating Edit Checks, Query Logics and User Acceptance Testing (UAT).
• Extensive hands-on experience during study conduct on Validating the data, Cleaning the data, Discrepancy management, Lab Reconciliation and SAE Reconciliation.
• Worked extensively on study closing activities including Data Review, Data freezing and Study Lock.
• Worked on compliance checking of data review guidelines in accordance with the regulatory guidelines.
• Knowledge in Medical Coding with WHO Drug
• Thorough knowledge in Database QC, CRF tracking and Database Auditing.
• Sound knowledge on ICH-GCP and 21 CFR Part 11 guidelines.
• Good verbal, written, interpersonal and communication skills.

Data Support Specialist, Parexel International PVT LTD Company ( June 2021 - June 2022)

• Conducting data entry into databases (Medidata Rave, DataLabs, iVal) and working on AZ Archiving on multiple studies.
• Tracking and scanning data into PXL Tools, performing quality checks of study data, and assisting in query management.
• Reviewing study-specific guidelines, creating Data Entry Guidelines and Data Management Plan.
• Participating in trainings, continuing to learn, and implementing new data entry and systems.
• Supporting administrative work for the Data Management Department, including training new DSS as a mentor.
• Creating a DSS Handbook for future reference and providing working direction to DSS proactively.
• Effectively managing time to meet daily metrics and adhering to agreed timelines in all activities.

Clinical Pharmacist @ Sakra World Hospitals, Bengaluru. (DEC-2020 to MAY-2021)

• Departments - General Medicine, Casualty, Pediatrics, Cardiology, Dermatology and General Surgery Responsibilities included:
• Daily ward rounds with physicians
• Critical analysis of prescriptions
• Counseled the patients on drug safety and non-prescription medications.
• Reporting and monitoring of adverse drug reactions.
• Provide drug and poison information.
• Case studies and presentations.
• Patient history interview.
• Ensure the compliance of management of medication as per NABH Requirement.