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Sakshi Paul
Sakshi Paul
Clinical Trial Lead / Medical Reviewer
Accomplished Clinical Research and Medical Review professional with over 11 years of experience managing global Phase II–IV clinical trials across multiple therapeutic areas, including Oncology, Psychiatry, Cardiology, Neurology, and Autoimmune Disorders. Proven expertise in clinical operations, medical and data review, protocol compliance, and regulatory coordination. Strong command of GCP guidelines, audit readiness, and cross-functional collaboration with global regulatory and medical teams. Adept at site oversight, quality documentation, risk mitigation, and study leadership from start-up to closeout.
FORMERLY AT
Biogen Idec India Pvt. Ltd.
LOCATION
Banglore
AVAILABILITY
Full-time
Skills
Clinical Data Review Tools
Clinical Trial Management
CTMS
eTMF
GCP Compliance
Medical & Data Review
Medidata Rave
Microsoft Office Suite
Oracle Clinical
Regulatory Submissions
SAE Reconciliation
Safety/SAE Tracking Systems
Site Monitoring
Work Experience
Clinical Trial Lead / Medical Reviewer
Biogen Idec India Pvt. Ltd.
Mar 2009 – Present
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Lead global and regional Phase II–IV clinical trials ensuring operational and regulatory excellence.
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Conduct medical and clinical data reviews for accuracy, consistency, and protocol compliance.
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Review key study documents — protocols, CRFs, ICFs, monitoring plans, and SAE reports — for adherence to ICH-GCP.
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Oversee site timelines, start-up activities, and investigator communications.
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Train and manage CRAs, vendors, and site teams to maintain compliance and data quality.
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Collaborate with global medical monitors on escalated clinical and safety issues.
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Ensure audit-ready documentation and resolution of quality findings throughout the study lifecycle.
TECHNOLOGIES
Oracle Clinical, CTMS, eTMF, Medidata Rave, Clinical Data Review Tools, Safety/SAE Tracking Systems, Microsoft Office Suite, Clinical Trial Management, Site Monitoring, Medical & Data Review, SAE Reconciliation, Regulatory Submissions, GCP Compliance,
Study Manager, Clinical Research & Development
Wyeth Pharmaceuticals India Ltd.
Sep 2007 – Feb 2009
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Managed end-to-end clinical study execution from feasibility to database lock.
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Conducted medical and data review across Oncology and Psychiatry studies.
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Coordinated regulatory submissions, EC communications, and document reviews.
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Supported global teams in medical monitoring, risk mitigation, and audit preparedness.
TECHNOLOGIES
Oracle Clinical, CTMS, eTMF, Medidata Rave, Clinical Data Review Tools, Safety/SAE Tracking Systems, Microsoft Office Suite, Clinical Trial Management, Site Monitoring, Medical & Data Review, SAE Reconciliation, Regulatory Submissions, GCP Compliance,
Clinical Research Associate (CRA)
PPD Inc.
Jun 2006 – Aug 2007
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Conducted site qualification, initiation, monitoring, and closeout for global Phase III trials.
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Performed medical review and data verification of AEs and source documents.
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Ensured compliance with ICH-GCP, FDA, and sponsor SOPs.
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Supported regulatory submissions and ethics committee approvals.
TECHNOLOGIES
Oracle Clinical, CTMS, eTMF, Medidata Rave, Clinical Data Review Tools, Safety/SAE Tracking Systems, Microsoft Office Suite, Clinical Trial Management, Site Monitoring, Medical & Data Review, SAE Reconciliation, Regulatory Submissions, GCP Compliance,
