Experience

Innovaderm Research Inc.

• Canada
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Lead Risk Based Monitor- Clinical Research

  • Mar 2022 - Present

  • Participate in the cross functional study team development of the Risk Assessment Management Plan (RAMP) and integrated data review planning. • Generate Central Monitoring and Surveillance Plan (CMaSP) to document central monitoring activities and assist the study team in review of planned key risk/performance indicators (KRI) and quality tolerance limits (QTL). • Provide technology vendors with required data transfer and study specifications for any central monitoring platforms. • Determine required dashboards for central monitoring activity and perform user acceptance testing with any required technology. • Perform and document the central monitoring of study data through periodic review, interpretation, of aggregate data against defined KRI and QTL. • Lead a review of the central monitoring output with study team members and recommend corrective actions for risk mitigation as described in the RAMP. • Track effectiveness of risk mitigation actions over time with study team members and provide escalation or additional recommendations if needed. • Create and maintain relationships with relevant internal departments, study sponsors, and with external CRO vendors, as directed, to ensure quality data in clinical trials through management of key risk/performance indicators and quality tolerance limits. • Manage the daily activities of the RBQM trials in accordance with Innovaderm SOPs and Good Clinical Practice. • Maintain relevant project documents and file required documents in the trial master file (TMF). • Attend regular team and client meetings, as requested. • Attend investigator meetings and provide support, as requested. • Participate in audits, as requested. • Participate and provide content for bid defense presentations, as requested. • Makes recommendations for improvements and contributes to the ongoing development of the RBQM Model. • Contribute to the education and knowledge of RBQM processes across the organization. Show less



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Manager Clinical Research Planning

  • Jun 2021 - Mar 2022



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Sr. Central Monitor

  • Jul 2018 - Jun 2021

  • Performs off-site data review, address more complex data related questions and recommends potential solutions; escalates issues which potentially impact study analysis. • Executes data validation programs and reports/listings to facilitate data review. • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution. • Issues clear, accurate and concise queries to investigational sites. • Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety. • Immediately communicates/escalates serious issues to the project team. • Documents observations noted during reviews, investigates trends, issues and risks for root cause • Creates action items as necessary in appropriate systems for action by sites, CRAs or other functional team members. • Actively participates in initial risk assessments and suggest various anticipated study specific risks. • Follows applicable database closure procedures for freezing, locking, and unlocking clinical databases. • Follows PRA and/or sponsor SOPs and work instructions and has a high level of knowledge of the protocol. • Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings as applicable and attends clinical training sessions according to the project specific requirements. • Performs QTL reviews. With support from cross-functional team, facilitates discussions on any mitigations or changes needed to functional plans. Is responsible for tracking Quality Tolerance Limits reviews, results and mitigations Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Global Central Monitor

  • Jun 2016 - Jul 2018

  • Risk based monitoring approach (Adaptive Monitoring - field / remote monitoring)• Core member of Clinical Trial Team (CTT)• Conducting/Attending - Country Calls, Trainings• Perform ongoing central monitoring of patient data using available online data sources (eCRF, IRT, Central Lab etc.) to ensure consistency, plausibility & correctness of data.• Communicate any deviations to clinical team, site regarding protocol, safety alerts, quality issues, trends & patterns, potential risks that may affect to the conduct of the trial.• Prepare & provide input for development of eCRF, Monitoring Plan (MP) Data Management Plan (DMP) Data Handling Plan (DHP)• Interact with DM, CAF, programming group & other line functions to ensure efficient data tracking• Listing Review• Central Continuous Remote Monitoring for ongoing medical / scientific review• Report generation as per project requirement with flags and alerts for relevant deviations.• Prepare & provide input for development eCRF Completion Guidelines, Study Specific Documentation (SSD)• Edit / Check Specifications (ECS) User Acceptance Testing (UAT)• Data Validation – Review, Cleaning, Verification, Reconciliation & Evaluation• Data Listings, Analysis & Quality Check (Data Base Lock & Interim Data Analysis)• In-Stream Data Review, Safety Report Review Show less

• Global Central Monitor

  • 2015 - Jun 2016

  • Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab etc.) to ensure consistency and correctness of the data• Communicate any observations; deviations to protocol, safety alerts, quality issues, entry patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and local ICRO organization / directly to site for timely follow-up actions and issue resolution.• Perform data query resolution process (with site, local ICRO CRA and DM )• As required update ClinAdmin or other study management systems with e.g. key trial country and site event dates and enrollment figures.• Provide input to the Monitoring Plan, eCRF design & review, and other documents and systems as applicable, ensuring accurate format for central monitoring.• Acts as a close partner with the local ICRO CRAs, CSMs and Global Trial Lead. A team member of the clinical trial team (CTT)• Interact with DM / CAF/ programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations.• As applicable support Group Head - Central Continuous Remote Monitoring for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks• Report generation as per project requirement with flags and alerts for relevant deviations• Updating study management systems (CTMS - CLINADMIN)• Data Listings, Data Cleaning, Data Analysis• Query Resolution / Discrepancy Management (with Site, CRA & DM)• AE/SAE Data Reconciliation• External Data Reconciliation (Patient Visit Data, Laboratory Data) Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Aug 2010 - Jan 2015

  Feasibility Study Site Selection & Study initiation On-Site Monitoring In-house Monitoring Study Termination & close out Having monitoring experience at International Centre for Diarrhoeal Disease Research, Dhaka Bangladesh (icddr,b). IVI, Korea Sponsored project. Number of subjects in the study was 204438. Feasibility Study Site Selection & Study initiation On-Site Monitoring In-house Monitoring Study Termination & close out Having monitoring experience at International Centre for Diarrhoeal Disease Research, Dhaka Bangladesh (icddr,b). IVI, Korea Sponsored project. Number of subjects in the study was 204438.



Uttar Pradesh Technical University, Lucknow

• India
• Higher Education
• 1 - 100 Employee

• Lecture

  • Mar 2008 - Jul 2010



M.K.C.G. Medical College, Berhampur

• India
• Higher Education
• 100 - 200 Employee

• Researcher

  • Jan 2007 - Mar 2008