Dr. Senthil Thyagarajan
About
Dr. Senthil Thyagarajan is from Pune Division, Maharashtra, India. Senthil is currently Founder Director & Head CRO at BioRadius Therapeutic Research Private Limited, located in Pune/Pimpri-Chinchwad Area. Senthil also works as Founder, Head CRO & Designated Partner at BioClin Research, a job Senthil has held since Jan 2015. Another title Senthil currently holds is Scientific Director and Partner at Novo Institute for Cellular Medicine.
Go to finalscout.com and type Senthil Thyagarajan's name into the search box for a free email address. FinalScout is a professional database with more than 500 million business professionals and 200 million company executives.
Dr. Senthil Thyagarajan's current jobs
My responsibilities as Head CRO were to: -Establish and maintain a global clinical research centre to conduct BABE and clinical trials. -Establish and ensure GXP compliance for conducting clinical research. -Ensure compliance to company wide QA standards and procedures, in accordance with global regulations. -Ensure regulatory affairs team is provided with quality approved data for regulatory submission. -Technical lead for business development with international and local clients. -Direct all studies as per GCP and GLP global regulatory guidelines. -Ensure facility approvals with DCGI, and global regulatory agencies (USFDA, MHRA,MOH Turkey, MHRA UK,MCC SA,ANVISA Brazil etc). -Keep abreast with latest development in clinical science.
-General & personnel responsibilities undertaken: Operation and administration of Lab, Licensure and Accreditions, delegation of authority, Staff selection, training, supervising, competency assessment, performance review -Facilities & Safety: Biosafety approval, chemical, hygiene and ergonomics control. -Test procedures: Method selection and validation, Quality control, Harmonization or standardization of procedures, New protocol generation and validation, Supervision of methods , processes and quality. -Quality management: quality programs, assessment, proficiency testing, inter-method comparisions, Audits, quality improvement. -Consultation and Education: Lab staffs , projects, result interpretation, therapeutic recommendations, trouble shooting, clinical education, institutional education. -Communication: Clinicians, patients, administration, risk management, regulators, accredition and certification bodies -Operational management: strategic planning, operational budgets, research and development, goal making. -Scientific responsibility: Research and development of new therapeutic Products, New project designing, protocol and experiment designing, grant writings, research papers and reviews.
Established hiPSC laboratory for drug screening assays, standardised iPSC derived NSC culture protocols, differentiated and characterised iPSC derived human neurons to be used for neurological drug screening high throughput assays