Dhanraj Baikerikar

• Executed comprehensive submission activities using Veeva RegVault to ensure thorough regulatory compliance. All the activities listed below are performed in the Regvault.
• Conducted checks on availability of RO (Regulatory Objective) and SO (Submission Objective) to ensure submission readiness and compliance with regulatory timelines.
• Uploaded and organized documents provided by Points of Contact (POCs) to create structured Submission Content Plans (SCP), facilitating efficient regulatory submissions.
• Managed DERs for creation and closure of Events, Activities, ROs, and SOs, streamlining submission workflows and addressing regulatory requirements.
• Executed archival of submission packages post-submission to Health Authorities, ensuring audit readiness and adherence to compliance standards.
• Maintained local templates in RegVault tailored to client-specific requirements, improving submission accuracy and consistency across regions.

• Supported global sponsored and supported R&D trials across all therapeutic areas, facilitating timely project execution.
• Coordinated study start-up teleconferences with study team.
• Assisted in study start-up activities, ensuring compliance with drug shipment protocols per sponsor SOPs.
• Update and maintain the data with accuracy and integrity within all relevant sponsor study Systems.
• Assist the study teams in the close out activities to ensure compliance to SOP and effective Study closure.
• Compilation and generation of Clinical Study Report Modular Appendices (List of Investigators and Study Administrative Table).
• Ensure the process KPIs defined are met for the study.
• Organize and participate in all appropriate meetings with sponsors and TCS.

• Monitoring of BA/BE studies and performing Site Initiation visit.
• Prepared and reviewed study monitoring plan, agenda, and study monitoring report to ensure compliance with regulatory standards.
• Retrospective audit of study documents such as MSR, CRF and ICF.
• Reviewing the eCDT report.
• Reviewing the Protocol.
• Preparation of Justification of Bio waiver
• Preparation and review of CRO Qualification report.
• Qualification audit conduction of CROs along with data review, and report preparation.
• Maintaining and updating SOP's on server.
• Performing Conducted thorough vendor audit to ensure compliance with quality standards..
• Executed archival of study and system data to maintain compliance and accessibility..
• Managed maintenance and archival of logbook to ensure accurate record-keeping..
• System upgradation as per organization and regulatory requirements.

• Period 2: 09th September 2019 to 04th February 2022
• Review of pre-study file, during file and post study files, vacutainer /vial labels, log books, completed ICF and CRFs in a timely manner.
• Conducted in-house monitoring studies to ensure compliance with protocols.
• Ensuring that all staff involved in the study are trained in protocol.
• Ensure that all the activities are being done as per the protocol, SOP's and GCP.
• Review of pre-study checklist to ensure that all requirements of the study are in place before study initiation, including the instruments used for the study are calibrated and have status labels on it.
• Reviewing study updates after completion of the study.
• Prepared statistical updates and communicated findings to relevant stakeholders.
• Reviewing of study updates after completion of the study.
• Checked activities for sample segregation and transfer to the analytical department as per sponsor requirements.

GPA: 74.14%

GPA: 56%

GPA: 78.72%