Rambabu Bittu

• Managed and coordinated global clinical trials across multiple regions, ensuring adherence to study protocols and regulatory requirements.
• Developing and maintaining comprehensive project plans, timelines, and budgets for international studies.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, data management, and biostatistics, to ensure seamless trial execution.
• Oversaw site selection, initiation, monitoring, and close-out activities in compliance with ICH-GCP guidelines.
• Implemented risk management strategies to identify and mitigate potential issues impacting study timelines and quality.
• Managed relationships with Contract Research Organizations (CROs) and other external vendors to ensure high-quality deliverables.
• Ensures timely and accurate data collection, entry, and analysis, maintaining data integrity and confidentiality.
• Prepare and submit regulatory documents, including Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, to global regulatory agencies.

• Support project management team to develop monitoring strategy including monitoring triggers/thresholds
• Identifying signals from risk monitoring strategies, undertaking root cause analysis and determine and assigning appropriate mitigation/action
• Conducting thorough risk assessments using the RACT to evaluate the impact and likelihood of identified risks.
• Based on KRI review and signal detection, assigns and documents task and related targeted site monitoring activities and follows up until completion
• Assisting team in analyzing QTL report Statistical monitoring report, and suggesting follow up actions
• Implement risk mitigation measures and monitor their effectiveness. Ensure that the RACT is used consistently and effectively across all relevant projects.

Leadership and Oversight:

• Lead teams involved in centralized monitoring activities various clinical studies through out Study start-up to Close out process.
• Serve as the primary point of contact for centralized monitoring activities, coordinating with global study managers, country operations leads, and CRAs
• Responsible for study oversight and delivery management, ensuring adherence to timelines, productivity, quality, and deliverables.
• Conduct periodic project review meetings with CRAs, country & global operation leaders, and other stakeholders for RBQM studies

Study Start-Up and Planning:

• Attend study level KOM to design Trial Monitoring Plans, Quality Tolerance Limits, and Key Risk Indicators.
• Coordinate with country and study cross-functional teams, acting as the main point of contact for global study managers, team members, and country operations leads.

Data Review and Risk Management:

• Perform ongoing remote data review to assess completeness and identify protocol deviations/violations.
• Analyze clinical trial data to identify trends, anomalies, and potential risks.
• Coordinate with the data management team to ensure all data cleaning processes are completed before database lock

Protocol and Safety Compliance:

• Review and understand protocols, critical data, processes, safety, and data integrity risks related to protocol execution.
• Review patient data listings and visualizations to confirm eligibility, identify protocol deviations, and address patient safety concerns.

System and Tool Management:

• Ensure accurate completion and maintenance of internal systems (e.g., CTMS), databases, tracking tools, timelines, and project plans.
• Assist programmers in creating Power Apps and Spotfire tools by providing specifications and performing UAT for the Central Monitoring group.

Vendor and Sample Management:

• Review Central Lab reports to confirm sample receipt and identify potential laboratory kit shortages.
• Access vendor systems to verify IP dispensation and administration, ensuring protocol adherence.

Issue Escalation and Resolution:

• Review action resolutions raised by Central Monitors and completed by CRAs, ensuring adequate issue resolution

Training and Coordination:

• Train assigned Central Monitors on project-specific requirements, protocols, systems, ad-hoc deliverables, and data operations.
• Coordinate with Data Quality Leads (DQLs) and statistical monitoring teams to address challenges in eCRFs and other study outputs.

• Overseeing centralized monitoring activities throughout the lifecycle of clinical trials, including study start-up, study conduct, and study closeout
• Interact with CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, Protocol deviations, etc.
• Review operational data using visualization tools and performing reconciliation of all activities of Trial monitoring plan topics such as from Recruitment to Study close out visits.
• Establish and maintain effective project/ communication with Country study managers (CSM) and CRAs of assigned studies on weekly/biweekly based or pre-defined timeliness.
• Review of Central Lab (E.g. LabCorp) reports to confirm samples and received as per schedule and oversight on Kit inventory. Ensure to Identify trends in sample management issues and queries in Rave EDC.
• Review IxRS for IMP receipt acknowledgement, expiration dates (including packs that may require destruction) and ensure adequate inventory levels.
• Supporting in Spotfire tool creation for ePRO/eCOA by providing input per protocol and ongoing reconciliation subject visits and Questionnaires completion.
• Performing reconciliation subject data in EDC with study systems such CTMS etc. and vendor systems like IXRS, Central/Local Labs.
• Provide site/country level trends/issues during country operations calls by reviewing various systems and operational data from visualization tools

• Coordinate the preparation and distribution of site initiation materials, including regulatory documents, study protocols, and informed consent forms.
• Ensure that investigational sites have all necessary supplies and equipment for the triaL
• Assist in the collection and review of essential regulatory documents from investigational sites.
• Ensure that all regulatory requirements are met before site initiation, including ethics committee approvals and regulatory authority submissions.
• Organize and conduct site initiation visits (SIVs) to train site staff on study protocols, procedures, and regulatory requirements.
• Provide ongoing support and guidance to site staff throughout the initiation phase.
• Coordinate with CRAs, project managers, and other stakeholders to ensure timely and efficient site initiation.

• Identify and screen potential study participants based on inclusion and exclusion criteria.
• Obtain informed consent from participants and ensure they understand the study procedures and potential risks
• Performs final review of test Clinical data/reports to ensure conformance to established specifications and other related standard operating procedures
• Schedule and conduct study visits, including physical exams, laboratory tests, and other assessments.
• Monitor participants for adverse events and report them to the appropriate parties.
• Conduct regular audits and quality checks to ensure adherence to the study protocol and regulatory requirements.
• Implement corrective actions as needed to address any issues or deviations
• Completes case report forms. Extracts data from patient file (Source documents) in timely manner.
• Proficient or developing proficiency in aseptic technique, microbiology lab operations, analytical methods, workstation tools (Word, Excel, etc.), and work process tools (LIMS)
• Collect, record, and maintain accurate and complete study data.
• Ensure data integrity and confidentiality in accordance with regulatory requirements.

• Design and execute laboratory testing according standard procedures, make observations and interpret findings
• Conduct experiments under defined conditions to verify/reject various types of hypotheses using refined scientific methods
• Organize and store all chemicals substances, fluids and compressed gases according to safety instructions
• Record all data and results in specified forms (paper and electronic) with accuracy and responsibility
• Maintain equipment and assist in ordering laboratory supplies