Bharat Shukla Email & Phone Number

Mumbai, Maharashtra, India

● Clinical domain consultation to internal teams as well as clients● Provide Risk Based Monitoring Support● Internal Training and Mentoring of teams working on various clinical project deliverables.● Support development team with clinical software developments● Working on, reviewing and finalizing clinical project related RFPs.● Develop training materials, reviewing and approving training content for clinical teams.

Mumbai Area, India

• Developing and implementing the Risk Based Monitoring and Site Report Review Model across various accounts.• Developing the study specific analytics strategy and working on advanced analytics.• Providing inputs to platform team for development and enhancement of RBM portal in alignment of RBM services model • Participating in RFP response and customer presentation for global pharmaceutical companies • Supporting TCS clinical services unit for generation of new business idea and further development • Contributing to development of SOPs, WI, and other operational documents • Providing inputs to generic, therapeutic and study specific KRIs development• Providing inputs for development of study dashboards and Spotfire reports• Conducting RBM specific training and awareness sessions for different cross functional teams and accounts in TCS #projectmanagement #riskbasedmonitoring #reportreview

Mumbai Area, India

• Responsible for the review of Site Visit Reports for multiple clinical projects.• Assist primary study Clinical Team Lead (CTL)/Clinical Project Managers (CPM) with the attainment of clinical deliverables within study timelines and budget by setting up clinical tools and processes for the study team.• Assist primary CTL/CPM with study set-up and follow-up study activities through ongoing tracking and review of study progress.• Assist with providing ongoing training and support to the clinical team. Help establish study tools and training materials. Co-conduct with the CTL/CPM frequent team meetings and ensure regular communication.• Contribute to the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the primary CTL/CPM/CSMQM and/or line managers.• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings.• Collaborate with CTLCPM to define annotations, Site Visit Report (SVR) guidelines and study tools (monitoring flow sheets and trackers) to assure efficient completion of SVRs by CRAs.• Work to decrease level of corrections/additions needed on reports by mentoring CRAs on report writing per annotations.• Escalation of CRA report writing and SOP submission compliance issues to the CTL/CPM and Line Manager.

Hyderabad Area, India

• Develop and deliver the risk-based monitoring plan training for Field Monitors (FM), • Prepare study-specific site & FM tools and updates them as needed, • Perform ongoing risk-based monitoring of patient data using available online data sources (eCRF, IVRS, Central lab etc.) to ensure consistency and correctness of the data for assigned countries.• 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 members for timely follow-up actions and issue resolution. • Acts as a close partner with field monitor for quality data output from respective sites during risk base monitoring phase.• Act as mentor to new team member for smooth induction and understanding the process of Risk Based monitoring.• Interact with Data management / Analytical / 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 for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks.• Adhere with corporate internal policies and requirements of PRA/RPS and Client (where applicable), including submission of RPS and Client timesheets as well as completion of trainings (where applicable) in timely manner. • Support Manager Central Monitoring in the preparation of training material and presentation related to the allocated project.• Assist in central monitoring project startup activities Author Monitoring Plan & Central Monitoring Plan and train worldwide CRAs and Central Monitors on these documents.• Provide inputs to the eCRF design and other documents and systems, as applicable.

Thane

• Coordinating all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines and SOPs. • Managing multiple investigative sites to determine and ensure protocol and regulatory compliance. • Lead role in coordinating and managing aspects of the clinical monitoring process and oversight of Clinical Research Associates.• Delegated responsibilities of the Project Manager. • Authorize to enforce study specific and company related policies and plans at investigative site level.• Authorize to make investigative site study specific decisions necessary for the successful and ongoing monitoring projects.• Authorize to train, mentor, and manage Clinical Research Associates(s).• Investigate site management and performance, including documentation of in-house and on-site monitoring activities for multiple investigative sites in accordance with designated project assignments (including applicable ICH-GCP and international/national regulatory requirements, and SOPs).• Monitoring reports on project status via the development, documentation and implementation of study tracking at the investigative site level.• Management and study-related training of all relevant personnel/positions at investigative sites.• Quality management through reporting of deviations and CAPA as required by SOP.• Problem/risk management.• Regular communicating with ongoing reporting and liaison with the Project Manager. • Training, mentoring, and managing of Clinical Research Associate(s) as delegated by the Project Manager. • Assume and or release other responsibilities as assigned by the Director, Clinical Operations & Quality Assurance or Clinical Operations Manager.

Mumbai

• Coordinating all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines and SOPs. • Managing multiple investigative sites to determine and ensure protocol and regulatory compliance. • Lead role in coordinating and managing aspects of the clinical monitoring process and oversight of Clinical Research Associates.• Delegated responsibilities of the Project Manager. • Authorize to enforce study specific and company related policies and plans at investigative site level.• Authorize to make investigative site study specific decisions necessary for the successful and ongoing monitoring projects.• Authorize to train, mentor, and manage Clinical Research Associates(s).• Investigate site management and performance, including documentation of in-house and on-site monitoring activities for multiple investigative sites in accordance with designated project assignments (including applicable ICH-GCP and international/national regulatory requirements, and SOPs).• Monitoring reports on project status via the development, documentation and implementation of study tracking at the investigative site level.• Management and study-related training of all relevant personnel/positions at investigative sites.• Quality management through reporting of deviations and CAPA as required by SOP.• Problem/risk management.• Regular communicating with ongoing reporting and liaison with the Project Manager. • Training, mentoring, and managing of Clinical Research Associate(s) as delegated by the Project Manager. • Assume and or release other responsibilities as assigned by the Director, Clinical Operations & Quality Assurance or Clinical Operations Manager.

Mumbai Area, India

• Coordinating all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines and SOPs. • Managing multiple investigative sites to determine and ensure protocol and regulatory compliance. • Lead role in coordinating and managing aspects of the clinical monitoring process and oversight of Clinical Research Associates.• Delegated responsibilities of the Project Manager. • Authorize to enforce study specific and company related policies and plans at investigative site level.• Authorize to make investigative site study specific decisions necessary for the successful and ongoing monitoring projects.• Authorize to train, mentor, and manage Clinical Research Associates(s).• Investigate site management and performance, including documentation of in-house and on-site monitoring activities for multiple investigative sites in accordance with designated project assignments (including applicable ICH-GCP and international/national regulatory requirements, and SOPs).• Monitoring reports on project status via the development, documentation and implementation of study tracking at the investigative site level.• Management and study-related training of all relevant personnel/positions at investigative sites.• Quality management through reporting of deviations and CAPA as required by SOP.• Problem/risk management.• Regular communicating with ongoing reporting and liaison with the Project Manager. • Training, mentoring, and managing of Clinical Research Associate(s) as delegated by the Project Manager. • Assume and or release other responsibilities as assigned by the Director, Clinical Operations & Quality Assurance or Clinical Operations Manager.

Mumbai Area, India

● Site Monitoring to ensure all relevant studies follow applicable SOPs, GCP and local regulations● To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current. Perform study site selection and qualification visits.● Also participated in investigator's meeting and site initiation visits. To identify, define, coordinate and conduct site study training.● Perform all study-related activities and regular monitoring visits to site.● To ensure the compliance to ICH-GCP guidelines, local & international regulations and applicable SOPs.● To verify the case report forms (CRFs) and source data according to the monitoring plan.● To ensure complete and accurate drug accountability.● To prepare monitoring reports and maintain audit readiness at the site level.● To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.● Speeding up the process of recruitment● To resolve all data queries or other study related queries from the site within timeframe. Conduct site close out and assure appropriate archival of controlled documents.● Training and discussing the monitoring plan and site follow up with CRAs and CTAs● To review research protocols and amendments, informed consent documents, case report form● Provide input into development of Informed Consent Form.● Maintaining good relationship with investigator, coordinator and study staff and encourage them to perform the research enthusiastically

Mumbai Area, India

Mumbai Area, India

Master Of Science, Clinical Research, A

Bachelor Of Science, Botany, A

Activities and Societies: active team lead of National Service Scheme during colleges days.

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