Akshay Shah
Senior Process Associate @Tata Consultancy Services
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WORK HISTORY
Senior Process Associate @Tata Consultancy Services
Pune, IN
CTIS (Clinical Trials Information Systems)• Study transition from EU-CTD to EU-CTR / CTIS(Clinical Trials Information Systems)• Preparation of CTIS for Clinical Trials under EURegulation.• Performing Quality check for CTIS Transitional and Initial studies.• Managing and responding to RFI\'s (Request for Information) in CTIS.• CTIS Portal monitoring for notices and alerts.Experience• Re-naming and uploading of documents and populating meta-data into CTIS.Veeva-Vault• Managing Vault Regulatory (RIM), Vault Clinical (e-TMF)- Veeva Vault.• Data Entry Requests, creation of Content Plans and Document Archival in Vault RIM (Veeva Vault).• Preparation and submission of Clinical Trial Applications in European region.Clinical Trial Applications - EU-CTD• Managing the submissions of Non-Substantial, Substantial Amendments and End of trials to EMA (European Medicines Agency).• Clinical Trial application submission via EudraCT, CESP (Common European Submission Portal) andCTIS (Clinical Trials Information Systems).• Tracking and responding to the HA (Health Authority) Correspondence.TGA portal• Submission of initial CTN, Variations and Completion advice notifications in TGAProject Specific roles• Attend and schedule kick-off meetings, weekly team meetings, and client meetings, as per the project specific needs.• Active involvement in Project meeting, study specific meetings, and distributes minutes of the internal and project meetings.• Develop and maintain project tracking tools.DSUR submissions in EU, UK and Switzerland.
EDUCATION
Sanjibhai Rupajibhai Memorial Trusts S.S.R. College of Pharmacy,U.T.Dadra Nagar Haveli, Sayali Silvasa 396230
Bachelor of Pharmacy - B-Pharm
Shri Chankya Education Societys Indira College of Pharmacy, Tathawade, Pune 33
Master of Pharmacy- M-Pharm
ABOUT AKSHAY SHAH
Global Regulatory Affairs Associate with expertise in EU CTR Submissions via CTIS, European Union Submissions via EU Directive, Regulatory Data, and Information Management System (RIMS), Australian CTN submissions via TGA and DSUR submissionWorking as CTIS submission specialist supporting clinical trial applications under CTA HUB model.Perform electronic data entry of clinical trial documents in CTIS and track the lifecycle in sponsors database using multiple tools (Liquent / Calyx RIM, Veeva Vault).Monitoring notifications meticulously (RMS, validation, assessments, Decision), tracking and Submitting RFI responsesHandled multiple Submissions via EU Directive including CTA amendments (Protocol amendments, ICF amendments, IB updates, IMPD changes), Health Authority Questions (HAQs), End of trial notificationsDemonstrate exceptional organizational skills by managing multiple concurrent projects and meeting all project milestonesReceived recognition and accolades for outstanding performance in CTIS submissions
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