Varundev Nagumanthri

• Executed the consultancy project as a team leader • Involved in conducting Secondary research • Facilitating team meetings with the goal to achieve the aims and objectives of the project • Conducted status update meetings with the project mentor and the client

I was responsible to establish a centralised team in India for Investigator payment in coordination with the finance team and eTMF Document management for Global studies. I was also responsible for project management tasks and provide support to Project Managers clinical phase I and Phase II studies globally.

I was responsible for reviewing the Critical Document Packages (Essential Documentation) for Investigator Product release in compliance with US FDA, EMA, ICH GCP guidelines, Sponsor, company's SOP's, study requirements and individual countries regulatory and ethics regulations.

I was responsible for remote data review of EDC, CTMS, IWRS and Lab Portals from the moment a study subject is enrolled till the termination or completion of subject visits to the clinical site using the IWRS trigger. I was also responsible for grading the sites using the KPI, KQI & KRI metric data indicators.

I was responsible for reviewing the Central, individual countries and study site files periodically to check for their completeness and legibility. I was also responsible for taking meeting minutes for client calls and updating the e-Clinical systems like e-TMF and CTMS.

I was responsible for building and promoting companies’ brands to healthcare professionals. I was also responsible for providing guidance and required clinical data to support the efficacy and efficiency of the drugs that are being promoted. I was also responsible for monitoring the competitor's products and reporting the sales data back to the company

International Business Environment & Trade, International Business strategy and Simulation, Global Marketing and an Intensive Project Management

Regulations in Clinical Research, Designing of clinical trials, protocol & CRF’s, study planning & management, review of essential documentation, Audit readiness & Pharmacovigilance.

Biomolecules, Analytical tools and techniques in Biotechnology, Enzymology & metabolism, Biology of Immune system, Microbial physiology, Genetics, Bioinformatics and Biostatistics.

Biotechnology, Biochemistry and Chemistry