Shashidhar M R Sharma

Clinical Research Associate with a proven track record at ICON Plc, adept in EDC and site monitoring. Demonstrates ability in leveraging Good Clinical Practice to enhance trial efficiency and data integrity. Skilled in fostering robust site relationships and ensuring compliance with regulatory standards, significantly contributing to project success.

• G7 Synergon Private Limited, Clinical Research Associate, 02/20, 01/23, Feasibility analysis, identification, and selection of Potential Investigators (PI)., Planning the conduct of the clinical study and developing study management systems., Prepare documents for ethics committee submissions., Planning and coordination of investigator meetings (IM) and prepare presentation materials., Management of recruitment strategies when necessary., Management and preparation of tracking documents., Management of study drug/supply/equipment delivery, shipment, inventory, and accountability., Create documents required by the project team prior to the start of the study (e.g. feasibility questionnaires, study tracking tools etc.)., Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to Project Manager (PM) to assist in site selection., Prepare, plan, organize and conduct site initiation visits., Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner., Collect and review essential documents from study sites., Monitor the conduct of clinical study as per protocol at multiple sites., Prepare, plan, organize and conduct the monitoring and close out visit as required., Establishment and maintenance of good clinical data collection practices to ensure validity of studies., Prepare, plan, organize and assist for an audit as required., Overall site responsibility and Central Lab coordination., Handling study related activities as per Duty delegation log of individual study., Folder management for the ongoing clinical studies and track of all the essential documents dispatched., Maintaining and updating the Project file., Responsible for implementation of corrective and preventive actions., Raising requests to QA for obtaining controlled documents., Raising requests for archiving the document.
• IQVIA, Sr. Clinical Process Associate (Site management Assistant), 08/17, 02/20, Filing of all the required documents in eTMF and eTMF Review., Performing CTMS tracking of Documents and Site ID related tasks in CTMS., Perform site and investigator payments which includes payment batch approval, reconciliation etc., Resolving the Action Items aroused from eTMF Review by contacting the respective document owner., Perform Site ID task which Includes Creation of PI, Sending the Invitation mails, QC of CDA etc., To assist the Global Clinical Lead and Project Lead in any assigned responsibilities., Attending project meetings to provide the status on eTMF for the project assigned., Have experience in working in more than one eTMF platform (Veeva Vault)., As a WML (Workflow management lead) acted as a Point of contact for many studies.

250, 200, 180, 150, 100, 100, 50, 50, 20, 0, III, Diabetes and obesity, Global, Study Monitor, III, Heart Failure, Global, Study Monitor, II, CKD, Global, Study Monitor, Pharmacokinetic Bioequivalence Study (Patient based), Advanced RCC, US FDA (Pilot Study), Study Monitor, Pharmacokinetic Bioequivalence Study (Patient based), Advanced Ovarian Cancer, US FDA (Pilot Study), Study Monitor, Bioequivalence Study (Patient based), Acne Vulgaris, USFDA, Study Monitor, Bioequivalence Study (Patient based), Acne Vulgaris, USFDA, Study Monitor, Bioequivalence Study (Patient based), Vulvar Vaginal Atrophy, USFDA, Study Monitor

• English
• Kannada
• Hindi
• Telugu

ICON Plc (FSP Novo Nordisk), Clinical Research Associate II, 01/23, 03/24, True, Performing monitoring visits according to plan, document actions and follow up on action plans., Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies., Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)., Train site staff in safety information handling and systems., Know and meet all local and company requirements with respect to safety reporting., Use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team., Identify potential risks and proactively take action to prevent or mitigate., Collaborate with Data Management/logistics in resolving queries., Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan., Manage trial product requirements, incl. temperature deviations and training of site staff., Ensure collaboration with and deliverables from vendors locally, if applicable., Collection and management of essential documents., Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)., Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable., Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)., Monitor and communicate internally any site observations critical to business results., Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements., Support audits and inspections at sites and affiliate, as applicable., Proficient use of Novo Nordisk systems.

Inform Oracle, Clindox, Veeva EDC, Calyx, CRFWEB (Clindox), 4G Clinical, COSMOS-Veeva, CTMS developed by IQVIA, eTMF developed by IQVIA, Veeva eTMF, Signant health, Clario, Connect portal, JUDI Portal, Octal soft