Avinash Thirumalacharya

About Avinash Thirumalacharya

As a naturally versatile, resourceful project and global data management professional, I have a proven background in the clinical trials arena, including knowledge of a range of therapeutic areas and clinical data management (CDM) systems, e-source systems and tools, with hands-on experience of all phases of CDM, from set-up of studies to database closure and quality control. I am dedicated to the ongoing growth and success of data management functions, where high standards of regulatory compliance are necessary.During my career, I have been recognised for exceptional leadership and management to take ownership of operations or projects and empower high team performance levels. I maximise influential communication skills to build cross-functional relationships at all levels, engaging with key stakeholders, multiple CROs and external vendors to verify data specifications, agreements and documentation.With a meticulous approach, I am efficient in lifecycle project management from initiation to resource planning and allocation, budget forecasting and cost control, risk analysis and mitigation, conflict resolution and workstream prioritisation. Furthermore, I define strategies for data management and study projects, share SDTM (study data tabulation model) knowledge and liaise cross-functionally to deliver training and develop systems.My credentials include a master of science degree and a bachelor of science degree. I welcome any further training to reach maximum career potential and continue professional development.Via LinkedIn, I am keen to expand my network of connections to include similar data and project management professionals, clinical organisations and recruiters to keep up to date with industry changes, trends and opportunities.I gained therapeutic experience of oncology, infectious diseases & vaccines, neurosciences, immunology, cardiovascular disease, endocrinology and respiratory. I also increased technical abilities by using RAVE, Inform, Oracle Clinical -RDC, DataLabs, ClinBase and LabPas, LSAF/SDD, HP-ALM, mCTMS, PRISM and Medidata coder.

Experience

1. Associate Director

   GSK

   Jan 2023 — Present · Bengaluru, IN

Education

• Kuvempu University

  Bachelor's degree, Biochemistry

  2002 — 2005

• Bangalore University

  M.Sc , Biotechnology

  2005 — 2007

Skills

• Sae Reconciliation
• U.s. Title 21 Cfr Part 11 Regulation
• Oc Rdc
• CRO
• Crf Design
• Clinical Research
• Oncology
• Clinical Trial Management System (Ctms)
• Project Management
• Data Reconciliation
• Global Data Manager
• Clinical Trials
• CRO Management
• Good Clinical Practice (Gcp)
• Management
• Clinical Data Management
• Oracle Clinical
• Standard Operating Procedure (Sop)
• Infectious Diseases
• Biotechnology
• Rave
• 21 Cfr Part 11
• Sdtm
• Pharmaceutical Industry
• Sop
• Validation
• Ich-Gcp
• Edc
• Data Management
• Ctms
• Life Sciences
• Inform
• Electronic Data Capture (Edc)
• Gcp
• Regulatory Submissions
• Clinical Development
• Vaccinations