Akash Mishra

About Akash Mishra

I am a Clinical Operations Team Leader and TMF Lead dedicated to ensuring global audit-readiness for high-stakes clinical research. With a deep focus on Veeva Vault eTMF, I specialize in transforming complex records management into a streamlined, quality-driven engine that meets the rigorous standards of global regulatory bodies.Currently, I lead a high-performing team of 13 TMF Specialists, overseeing the end-to-end documentation lifecycle for high-priority Phase Oncology trials. My role is dual-faceted: I manage the operational delivery of high-billing, high-impact projects while serving as a Subject Matter Expert (SME) and Trainer to ensure technical excellence across the board.Why I am a valued partner in Clinical Research:• People Leadership: I manage a team of 13, focusing on resource optimization, performance mentoring, and maintaining 100% quality compliance in a fast-paced environment.• Oncology Specialization: I handle the unique complexities of Oncology trials, ensuring that high-volume, high-frequency data is captured with precision.• Strategic Audit-Readiness: I don\'t just manage files; I build frameworks for inspection readiness, proactively identifying gaps and mitigating risks before they reach the audit stage.• Operational SME: As a trainer and SME, I bridge the gap between technology (Veeva) and process, ensuring my team and projects consistently exceed client expectations and billing milestones.I thrive at the intersection of leadership and technical precision, ensuring that the critical data behind life-changing therapies is secure, compliant, and ready for the world.

Experience

1. Team Lead, Tmf Lead Specialist

   Tata Consultancy Services

   May 2025 — Present · Thane, IN

   Daily Focus:• Leading a team of 13 dedicated TMF specialists, providing daily guidance and hands-on support to ensure our clinical trial master files are always accurate and inspection-ready.• Acting as a coach and mentor, I focus on each team member\'s growth, helping them navigate complex TMF issues and develop their skills.• Guiding the team to deliver high-quality, compliant TMFs by setting clear goals, managing workloads, and fostering a collaborative environment.Key Achievements:• Successfully led the team through a period of significant growth, building a cohesive unit and improving overall efficiency by 20%.• Implemented new quality control processes that reduced TMF-related audit findings, strengthening our compliance and reducing risks.• Empowered team members through one-on-one mentoring, leading to several internal promotions and a noticeable increase in team morale and ownership.• Served as the primary point of contact for TMF-related questions and escalations, providing strategic support to cross-functional study teams.Leadership Philosophy:I believe a strong team is built on trust, clear communication, and a shared commitment to excellence. My goal is to not only ensure our TMFs are in perfect order but also to empower every person on my team to reach their full potential.

Education

• Carmel High School

  Secondary School Certificate (S.S.C), High School/Secondary Certificate Programs

  2005 — 2006

• NMIMS CDOE

  Post Graduate Diploma in Business Management, Business Administration and Management, General

  2020 — 2022

• Clinomic Center for Clinical Research Pvt. Ltd.

  Post Graduate Diploma in Clinical Research, Clinical/Medical Laboratory Science/Research and Allied Professions

  2019 — 2020

• University of Mumbai

  Bachelor of Science (B.Sc.), Chemistry

  2012 — 2015

• Bharati Vidyapeeth

  Diploma in Pharmacy, Pharmacy

  2008 — 2010

• Bharat Junior College of Arts, Commerce and Science

  Higher Secondary School, Science

  2006 — 2008