AKANKSHA KHOSLA
@akankshakhosla1
Clinical Data & TMF Specialist improving trial quality through ICH-GCP compliance.
IndiaWhat I'm looking for
I’m a Clinical Data & TMF Specialist with 3+ years of experience managing Trial Master File (TMF) documentation and clinical data quality for live, multi-study trials. I focus on audit-ready processes and proven ICH-GCP E6(R2) compliance.
In my TMF Document Specialist role, I managed end-to-end TMF documentation across multiple concurrent trials and supported study start-up through close-out. I tracked document completeness in Excel-based trackers, identified gaps, and escalated deviations to preserve data integrity across CRAs, PMs, and Regulatory Affairs.
I produce structured status reports and data summaries that translate complex regulatory information into clear, actionable updates for study leads. I also supported internal audits and inspection-readiness reviews, with zero critical audit findings attributed to TMF documentation.
Alongside clinical operations, I’ve built strong analytical capability through data science research work using Python and R. I’ve also published across peer-reviewed journals, and I bring that same clarity and rigor to scientific/regulatory writing and cross-functional communication.
Experience
Work history, roles, and key accomplishments
Managed end-to-end TMF documentation for multiple concurrent live clinical trials, maintaining audit-readiness and ICH-GCP E6(R2) compliance. Tracked document completeness, escalated gaps/deviations, and produced structured status reports for study leads.
Sr. Subject Matter Expert
Evelyn Learning Systems
Jan 2020 - Jan 2021 (1 year)
Quality-assured CBSE/ICSE Biology curriculum content for Classes 6–12 and provided QA oversight to junior SMEs. Maintained high accuracy across thousands of content reviews.
Delivered verified, step-by-step Biology solutions with consistently high accuracy ratings. Supported learners by providing clear subject explanations and problem-solving steps.
Peer Moderator - Science & Health
Fortis Hospital
Jan 2016 - Jan 2019 (3 years)
Communicated complex health and science concepts to patients and their families. Provided peer support by translating technical information into clear explanations.
Data Science Research Trainee
MedTourEasy
Jan 2021 - Present (5 years 6 months)
Collected, cleaned, and analyzed multi-source healthcare datasets to produce evidence-based research outputs. Produced structured analytical reports for research leads and identified trends across patient datasets.
Education
Degrees, certifications, and relevant coursework
Delhi Technological University (DTU)
Master of Science in Biotechnology, Biotechnology
2019 - 2021
Grade: CGPA 9.49/10; 1st Rank in Department
Activities and societies: GATE-BT 2021 (Rank 396); IIT-JAM BL 2021 (Rank 85)
Master of Science in Biotechnology at Delhi Technological University (DTU) (2019–2021), graduating with CGPA 9.49/10 and 1st rank in the department. Dissertation defended before a five-professor jury.
Ramjas College, University of Delhi
Bachelor of Science in Life Sciences, Life Sciences
2016 - 2019
Grade: CGPA 8.864/10
Bachelor of Science in Life Sciences at Ramjas College, University of Delhi (2016–2019) with CGPA 8.864/10. Received best undergraduate student and Biology subject topper (Class XII) recognition.
Availability
Location
IndiaAuthorized to work in
Job categories
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