Akshay Goud

About Akshay Goud

I am a Post Graduate in Biochemistry an enthusiast person who has positive approach towards professional life who is passionate about making a positive impact in the healthcare and clinical research industry. I am eager to learn more about the industry and to work in a fun and challenging working environment that will encourage me to improve and learn new and necessary skills as well as be motivated by the company to do best for the sake of helping myself and the company advancement in the Research industry.

Experience

1. Regulatory Site Activation Specialist

   IQVIA

   Jul 2022 — Present · Maharashtra, IN

   Manage assigned opportunities/projects/programs for country or region and adhere to timelines and budget.\\\\n- Collection of Essential documents from PI’s via email or DocuSign as per their preference. Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents and ensured site personnel are trained and are ready for site activation.\\\\n- Nordic Site ID lead for all four countries Sweden, Norway, Denmark & Finland handling the allocation of new studies coming in Feasibility phase. Worked on site outreach part for feasibility studies with studies specialization in oncology, neurology, dermatology, COVID exposure studies. Driving studies from feasibility to Site ID phase by sending out CDA’s, Feasibility questionnaires to site using drug dev feasibility system, updating CTMS with comments from PI’s and doing the handover to SSV CRA.\\\\n- Ensures the site list for assigned studies includes an adequate number of appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.\\\\n- Attend kick off meetings to understand study requirements include investigator profile, protocol, process specifics and timelines.\\\\n- Sending out Site selection letter and Site ready to enroll forms to PI’s to fill out.\\\\n- Ensuring completeness, site capability and suitability for the study. Also, updating and maintaining the internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.\\\\n- For SID review SIF and/or SSQ vs the guidance document and approve for SSV or select appropriate sites. Manage investigator database entry and quality, ensuring complete investigator and site information is captured and monitor for duplicate entries.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• Occupational Therapy School & Centre, Lokmanya Tilak Municipal Medical College, Mumbai

  Master's degree

  2017 — 2019

• B.n Bandodkar College

  Bachelor's degree

  2014 — 2017