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Ajay Sharma
Clinical Operations Manager
Clinical Operations Manager
Clinical Research Professional with 8+ years of progressive experience in clinical operations, site management, and end-to-end trial execution across multiple therapeutic areas including immunology, endocrinology, virology, oncology, and gastroenterology. Proven expertise in managing Phase II–IV studies, overseeing site readiness, monitoring activities, ensuring protocol adherence, and maintaining regulatory compliance (ICH-GCP, NDCT). Adept at budgeting, CTA negotiation, SOP development, audit preparedness, and team leadership. Skilled in leveraging clinical systems such as Medidata Rave, Veeva Vault, Octalsoft, Clinion, REDCap, and CTMS/eTMF platforms to ensure data integrity, documentation accuracy, and operational efficiency across India, Nepal, and Africa.
FORMERLY AT
Croissance Clinical Research
LOCATION
Hyderabad
AVAILABILITY
Full-time
Skills
Accelient eClinical Suite
Almac
Calyax
Clinion
cubeCDMS
Endpoint IRT
Medidata Rave
Medidata RTSM
Octalsoft
REDCap
Siebel Clinical
Signant Health
Veeva Vault
Viedoc
Work Experience
Clinical Operations Manager
Croissance Clinical Research
Feb 2023 – Present
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Lead and mentor clinical teams on protocol adherence, regulatory compliance, and study processes.
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Manage study budgets, negotiate Clinical Trial Agreements (CTAs), and monitor project financials.
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Develop SOPs, monitoring plans, and quality oversight strategies; conduct co-monitoring visits.
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Conduct investigator meetings, internal audits, and client review meetings.
TECHNOLOGIES
Medidata Rave, Veeva Vault, Octalsoft, Clinion, REDCap, Signant Health, Almac, Viedoc, Endpoint IRT, cubeCDMS, Calyax, Siebel Clinical, Accelient eClinical Suite, Medidata RTSM
Senior Clinical Research Associate
Croissance Clinical Research
Sep 2021 – Jan 2023
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Oversaw study start-up and feasibility activities across multiple trial sites.
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Reviewed monitoring reports and mentored CRAs for protocol and data quality compliance.
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Trained site staff on study processes, regulatory compliance, and documentation standards.
TECHNOLOGIES
Medidata Rave, Veeva Vault, Clinion, Octalsoft, REDCap, Siebel Clinical
Clinical Research Associate
Croissance Clinical Research
Oct 2019 – Aug 2021
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Conducted site monitoring, SDV, ISF/TMF updates, and visit documentation.
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Managed site payments, query resolution, and completed 180+ monitoring visits.
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Mentored site staff to ensure adherence to protocol and GCP compliance.
TECHNOLOGIES
Medidata Rave, Octalsoft, Clinion, REDCap, Endpoint IRT, cubeCDMS
