Priya Temkar

www.courseinov.com - eLearning Course Creator, Curriculum Developer & Instructional Designer.

-Consultant monitoring & evaluations, digital health records management & information systems, proposals & grant writing, at NGOs in public health space. -Personal non-profit endeavors in traditional art & handicrafts, established during the pandemic phase.

Responsible for Clinical Operations subject matter expertise, capability framework development &offering management for Top 3 global pharma clients, Developing competency-framework, training curriculum, SOPs &WIs, Development of E-site-feasibility tool, to accelerate Study Start-up. Responsible for authoring RFI/RFP responses & working on proposals development; Publishing white papers in national and international journals; Capability growth ~50%, from 150 FTEs to 300 FTEs in the years 2014 to 2017.

CMA III (India): Responsible for Centralized remote monitoring of multiple clinical trials in phase II & III from various therapeutic indications, in compliance with ICH-GCP guidelines, applicable country regulations like DCGI, US FDA, Client SOP’s and Protocol. CRA II (Australia): Responsible for conducting on-site monitoring visit to 9 clinical trial sites across hospitals in Melbourne, ensuring compliance to ICH-GCP, CFR, TGA regulations, sponsor SOP’s and monitoring plan.

Functional Project Management of IVRS/IWRS projects for drug supply & inventory management. SPOC for pharma sponsors and project stakeholder for user-requirements. Authoring all project specifications like user requirements, materials & randomization specifications, and end-to-end system lifecycle (SLC) management.

Clinical Project Associate - Responsible for Administration and Governance activities on global mega-trial involving 2000 patients and running across 20 countries; Managing documentation, clinical trial logistics and quality issues, in compliance with ICH-GCP and applicable regulatory/competent authorities in EU (MHRA, Swiss Medic, EMA, BfArM etc.), for 7 Countries.

Responsible for leading a team of 5 monitors, for a multi-centric national trial, conducted across 11 sites in India. SPOC for sponsor and all trial stakeholders. Back-up for project manager and responsible for on-site monitoring & compliance of all sites.

Laboratory research work, Analytical Method Development, Routine Drug-Analysis, Stability testing and report writing.​

1.IBM - Introduction to Artificial Intelligence – 9 June 2023 2.International Association of Privacy Professionals (IAPP) - AI Governance Professional (AIGP) – 5 Jun 2024 3.Alan Turing Institute - Fairness and Responsibility in Human-AI Interactions (Medical Setting) – 15 Nov 2023 4.Stanford - Introduction to AI (Healthcare Specialization) – 12 May 2023 5.Delft University – Ethics in AI Design – 2 Nov 2023 6.IEEE – AI Ethics awareness 7.IBM – Fundamental of Generative AI

Certification No. CBMG1620NB788

Certification No. 2012 0001039 AGS Training & Consulting Project Performance Group & GAPPS