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Aditi Mishra
Clinical Operations Manager
Clinical Operations Manager
Clinical Operations Manager with 9 years of experience leading end-to-end clinical trial execution across interventional and non-interventional studies in Diabetes, Cardiology, and Hemophilia. Proven track record in establishing clinical research functions from the ground up, managing cross-functional teams, and ensuring regulatory compliance with ICH-GCP and global standards. Skilled in project planning, site/vendor management, budgeting, and operational oversight. Adept in using CTMS, EDC, and eTMF systems to drive study efficiency, improve data quality, and maintain inspection readiness. Recognized for strong leadership, stakeholder collaboration, and delivering high-impact clinical programs aligned with organizational and regulatory requirements.
FORMERLY AT
Novo Nordisk
LOCATION
Egypt
AVAILABILITY
Full Time
Skills
Clinical Tracking & Budget Systems
CTMS
CTMS (IMPACT)
EDC
EDC Systems
eTMF
Microsoft Office Suite
MS Office
Tracking Systems
Trial Budget
Work Experience
Clinical Operations Manager
Novo Nordisk
Nov 2013 – Present
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Established the Clinical Research Department and built a high-performing operations team.
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Lead end-to-end clinical trial operations (startup → conduct → closeout) across interventional and non-interventional studies in Diabetes, Cardiology & Hemophilia.
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Develop country-level recruitment strategies, risk mitigation plans, and operational KPIs.
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Oversee regulatory submissions and serve as primary liaison with Health Authorities & Ethics Committees.
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Manage vendor selection, contracting, performance oversight, and budget alignment.
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Lead team development activities, training programs, and performance evaluations.
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Maintain operational excellence and compliance with global ICH-GCP and local regulations.
TECHNOLOGIES
CTMS (IMPACT), EDC Systems, eTMF, Clinical Tracking & Budget Systems, Microsoft Office Suite
Local Trial Manager
Novo Nordisk India Pvt. Ltd.
Nov 2012 – Oct 2013
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Managed interventional clinical studies across multiple investigator sites (Type 2 Diabetes, CV outcome trials).
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Oversaw study timelines, monitoring planning, site performance, and trial budgets.
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Coordinated communication between sponsors, investigators, and internal study teams.
TECHNOLOGIES
CTMS, EDC, eTMF, Trial Budget, Tracking Systems, MS Office
Clinical Research Associate
Novo Nordisk India Pvt. Ltd.
Apr 2010 – Oct 2012
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Conducted site initiation, monitoring, and closeout for Phase III–IV studies.
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Ensured protocol adherence, source data verification (SDV), and data quality oversight.
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Collaborated with cross-functional teams for timely query resolution and study progress updates.
TECHNOLOGIES
CTMS, EDC, eTMF, MS Office
