Racharla Venugopal
PMP | Clinical Research Professional
Hyderabad
Summary
Clinical Research professional with 12+ years of experience in the healthcare and Project Management. Proven ability to align team goals with organizational objectives. Strong communication and collaboration skills, ensuring effective cross functional teamwork.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Clinical Trial Support Manager
Sanofi
06.2025 - Current
- Clinical Trial Support Manager (CTSM) supports the GSM to enhance the study quality outcome from study setup to study closeout.
- Participating in the study set up activities.
- Supporting the preparation of study documents, such as the monitoring plan, SRMP, central monitoring plan, study communication plan, recruitment, and retention plan, etc.
- Vendor management activities from study setup to study closeout.
- TMF setup and oversight at the study level.
- Participate in the preparation of audits, and contribute to elaborating proper responses to audit and inspection reports.
- Collaborate with cross-functional teams to enhance the study progress on track.
- Review country and study-level metrics to identify performance deviations, safety concerns, or protocol noncompliance.
- Conducting additional biweekly calls with the core study team to discuss the study status.
Assistant Project Manager
TATA Consultancy Services
06.2024 - 11.2025
- Served as the primary contact for the sponsor, vendors, and internal team throughout the study.
- Communicates effectively with sponsors, study team members, functional departments, and senior management.
- Proactively manages the operational aspects of the clinical trial, including trial timelines, budget, resources, and vendors.
- Coordinates tasks and deliverables from all functional departments involved in the project.
- Controls the project budget by ensuring that project team members understand the hours allocated for each task, and review the time billed to the study against the budget to control write-offs and identify out-of-scope activities for change orders.
- Provided efficient updates on trial progress to the internal and external stakeholders, with respect to site selection, vendor selection, project plans, trial budget, and timeline management, quality standards, and risk mitigation.
- Acts as Lead for the study start-up process, site selection and finalization of site lists, site activation, management of vendor setup timelines, and site contracting, and budgeting.
- Analyzed discrepancies between planned and actual results, and participated in the development and implementation of corrective actions to be taken as needed.
- Ensured that the project-specific training matrix is customized to each study and maintained accurately throughout the study.
- Provided project status updates to external and internal stakeholders, ensuring compliance with the study budget, project scope, and timelines, and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory, and study-specific requirements.
Sr Centralized Monitor
IQVIA
02.2019 - 05.2024
- Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines. To work with multiple CRAs as the owner the multiple studies to enhance the site activity, Risk Based Monitoring, Real Time Data Review, maintaining site supplies, Site payments, to closely works with RCTM/LTMs.
- Prepare CRA briefcase to take appropriate action to enhance the site activity.
- Contribute to the development and use of study management plans and/or DTE specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study.
- Complete study monitoring in the site level, country level and study level data.
- Review and works on Protocol deviation management system.
- Effectively communicate with RCTM and GCTM for site management functions.
- Review the KRIs and find the RISK at site level by using multiple tools and MVRs.
- Make a cleared/appropriate report on RISKS at the site level to trigger any action Items.
- Support project management team to develop monitoring strategy including monitoring triggers/thresholds.
- Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.
- Provide Centralized support to monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
- Perform Subject Level Data Review that requires further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall accuracy of the information.
- Perform direct site contact where it’s really required to enhance the site activity to wards data flow, ICF amendments, protocol procedures.
- Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team.
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned studies.
- In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data, performing the trend analytics for their respective studies.
- Establish regular lines of communication with sites to manage ongoing project expectations and issues.
Sr. Clinical project associate
Fortrea
04.2018 - 02.2019
- Managed end-to-end execution of clinical studies, ensuring adherence to SOPs, policies, and regulatory requirements.
- Reviewed structured clinical data output and facilitated efficient site visit reports.
- Ensured subject safety, data integrity, and timely feedback in compliance with ICH GCP guidelines.
- Developed study management plans and performed risk-based monitoring.
- Collaborated with project teams and supported continuous process improvements.
Sr. Clinical Process Associate
IQVIA
04.2016 - 03.2018
- 100% review QC role for clinical and non-clinical study documents as study and subject documents (protocols, regulatory documents, CTMS documents, Internal business records, Agreements, FDA1572, Communications, Ethics committee and regulatory submissions packs, IMP documents, site management documents and etc.)
- Maintain eTMF record and archive as per regulatory requirements for documentation.
- Ensure to file all the documents without missing content in the document, quality, and signatures.
- Ensure to follow the organization SOPs and EDC process.
- Review the TMF documents as site, country, and core level documents.
- Verify the document data quality, accuracy, efficacy, and image QC.
Clinical Research Associate
MTR Research Labs
06.2014 - 03.2016
- Actively participated in the study level meetings with PMs, PIs, CMOLs, CLs to discuss on study/country/site level updates.
- Perform SIV/SAV and provide the protocol/IP trainings to site staff.
- Conduct onsite/remote visits according to the MV schema which has been assigned by the RCTM.
- Collect subject level data to verify in SDR/SDV.
- Conducted onsite monitoring activities and remind the timelines if any discrepancies noted.
- Participated in ethics committee submissions and regulatory submissions.
- Ensured to contact with site Principal investigator regarding the instruments, enough staff members for activities, pharmacy conditions, availability of the persons as per protocol requirements.
- Communicated with IRB/IEC board for approvals and updates on trial progress and subject enrollments.
- Monitor and lead activities as subject recruiting, study activities, medications.
- Communicated with individual departments to collect documents and provide training.
- Ensure to follow SOPs for handling of investigational products, documentation, storage conditions and retention.
- Ensured the subject safety and maintain the records according to regulatory requirements.
- Recording adverse events and serious adverse events and safety follow-up for the subject and submit the reports to the institutional review board and sponsor.
- Communicated with CEC regarding the ongoing updates and summary of the study.
- Managed QA, IRB, sponsor queries, and escalated queries to the project department.
- Communicate the internal departments for improve the quality.
Education
Master of pharmacy -
KPTC College
Bachelor of Pharmacy - undefined
S. Chaavan college of pharmacy
NelloreSkills
Clinical Operations
Regulatory Compliance
Clinical Monitoring
CTMS
eTMF activities
Project Management
Stakeholder Engagement
Problem Solving
Team leadership
Adaptability
Communication
Teamwork
Accomplishments
- Within a short period, I was selected as the best QC reviewer in the MTR organization.
- Successfully completed my ICH GCP course at Quintiles IMS with 95% marks.
- Selected for the NOVARTIS sponsor-specific process for eTMF transformation according to the sponsor's specific guidelines and requirements.
Certification
Certified PMP professional
Timeline
Clinical Trial Support Manager
Sanofi
06.2025 - Current
Certified PMP professional
09-2024
Assistant Project Manager
TATA Consultancy Services
06.2024 - 11.2025
Sr Centralized Monitor
IQVIA
02.2019 - 05.2024
Sr. Clinical project associate
Fortrea
04.2018 - 02.2019
Sr. Clinical Process Associate
IQVIA
04.2016 - 03.2018
Clinical Research Associate
MTR Research Labs
06.2014 - 03.2016
Bachelor of Pharmacy - undefined
S. Chaavan college of pharmacy
Master of pharmacy -
KPTC College