Laxmi M.

About Laxmi M.

Global Clinical Research Industry Experience, Phase I-IV trials – Vast experience in Site Recruitment Visits, Pre-Study Site Initiation Visits (PSSVS), Site Initiation Visits (SIVS), routine/interim (RMVs/IMVs), close-out (COVs) and assisted in FDA Audits and Sponsor Audits- Facilitating Investigator Meetings, Presentations, and Seminars, Protocol Writing, Developing Budgets, CRFs, SOPs and Training Material for Sponsors- Contracting and negotiation with third party vendors such as CROs, Labs, Data Management team- Training In-house team & draft study designs, protocols and CRFs, feasibility with CROs- Responsible for accurate and timely Data Collection, Documentation, Raising Queries and Reporting- Proven ability to work both independently and in a team environment as project/study resource to ensure goals and deadlines are met within company/FDA regulatory guidelines- Maintaining, Documenting & Conducting the Quality Assurance and Review of TMF and Site Files.

Experience

1. Senior In-house Cra

   Astellas Pharma

   Mar 2024 — Present · US

Education

• Harrisburg University of Science and Technology

  Master of Science (MS), Information Systems Engineering and Management

  2014 — 2016

• Cranfield University

  Master's degree, Clinical Research

  2007 — 2009

• Cranfield School of Management

  Post Graduate Diploma, Clinical Research Operation Management

  2008 — 2009

• University of Northern Virginia - Annandale

  Master of Business Administration (MBA), Pharmaceutical Marketing and Management

  2010 — 2012