Prasanna Oggu
Chennai
Summary
Dedicated Clinical Data Manager with 3.4 years of experience in healthcare and pharmaceutical industries. Highly skilled in managing and analysis of clinical trial data to ensure accuracy, completeness, and compliance with regulatory standards. Expert in study conduct data management activities. With my expertise, I have handled complex studies and all data management activities in study start-up, conduct and closure. Strong communicator with a keen eye for detail and a commitment to delivering high-quality deliverables.
Overview
3
3
years of professional experience
Work History
Clinical Data Manager
Zifo technologies
Chennai
08.2021 - Current
- Clinical Data Manager with expertise in Phase Ib/II, II, III, and IV studies covering diverse therapeutic areas like neurology, hematology, oncology, vaccines, endocrinology, and metabolic diseases.
- Experience in managing clinical data for trials conducted in Rave, Viedoc, and Zelta EDCs.
- Experienced professional in conduct activities including data review, query management, safety data reconciliation, external lab data reconciliation, data quality assessment, answered query review, page status update, medical coding, handling protocol deviations, and report creation.
- Working experience in MedDRA and WHODrug dictionaries as a part of medical coding.
- Experience in study start-up activities, such as drafting documents including CRF completion guidelines, schedule of events, data management planning, and manual review plan.
- Experience in study setup activities such as CRF specification creation, eCRF build, edit checks specification creation, edit checks UAT, and UAT plan creation.
- Experience in study closure activities like final data cleaning, DMR creation, archival, and binder.
- Tested edit checks for data entry, database development, and report generation.
- Working experience as a lead data manager for studies in the conduct phase.
- Highly experienced as a reviewer for the DM activities performed by team members.
- Worked closely with other departments, such as biostatistics, medical writing, and regulatory affairs, in order to ensure timely completion of projects.
- Ability to attain, maintain, and apply a working knowledge of GCP and applicable standard operating procedures.
- Understands the significance of regulations such as 21 CFR Part 11, standards and models such as CDASH and SDTM, the principles of clinical research, GCP, and GCDMP.
Education
Bsc Biotechnology -
ZifoB.S.Abdur Rahman Crescent Institute of Science And Technology
Skills
- Experience in planning, executing and overseeing projects to ensure timely completion
- Skilled in prioritizing stakeholder expectations, adapting to changing requirements, clearly communicating updates to team members
- Experience in training and guiding team members for data management activities
- Experience in customer and project management handling for data management activities
- Actively participates in team meetings and effective in communication and experienced in content presentations
- Involved in updating department level SOPs as per the current practice
Publications
Decentralized Clinical Trials
Timeline
Clinical Data Manager
Zifo technologies
08.2021 - Current
Bsc Biotechnology -
ZifoB.S.Abdur Rahman Crescent Institute of Science And Technology
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