Aparna Dronamraju
Hyderabad,
Summary
Results-driven clinical research professional with over a decade of experience in clinical trial management, operational oversight, and regulatory compliance. Adept at leading cross-functional teams, optimizing clinical trial workflows, and ensuring alignment with industry standards, including GCP, GDP, and 21 CFR Part 11. Proven ability to drive process improvements, manage study conduct, ensure data integrity, and oversee clinical database management through strategic oversight and collaboration. Strong leadership, problem-solving, and stakeholder engagement skills, with a passion for innovation in decentralized clinical trials (DCT), electronic clinical outcome assessments (eCOA), and advanced clinical data management (CDM) technologies.
Overview
14
14
years of professional experience
Work History
Source Configuration Specialist
OneStudyTeam - Reify Health
01.2024 - Current
- Expert in eCRF design and data standardization, ensuring alignment with CDASH, SDTM, and ICH-GCP standards
- Led User Acceptance Testing (UAT) and System Validation Testing, ensuring compliance with 21 CFR Part 11 and GCP guidelines
- Designed and developed electronic Case Report Forms (eCRFs) using industry standards such as CDASH, SDTM, and ICH-GCP
- Configured and validated eSource templates, ensuring seamless integration with clinical data platforms and regulatory compliance
- Implemented and reviewed edit checks, discrepancy management, and validation listings to maintain data integrity and accuracy
- Developed workflow automation for eCRF design and clinical data review, reducing turnaround times and improving efficiency
- Collaborated with global cross-functional teams to optimize clinical data workflows, troubleshoot technical issues, and enhance data-driven decision-making
Manager, Clinical Operations
Imaging Endpoints Pvt Ltd.
Hyderabad
01.2023 - 10.2023
- Led the execution of oncology clinical trials specialising in paediatric and geriatric populations, ensuring alignment with protocol requirements and regulatory standards
- Managed TMF maintenance and ensured audit readiness, facilitating successful sponsor and regulatory inspections
- Implemented risk-based monitoring strategies, proactively identifying and resolving data discrepancies
- Managed data integrity and quality control processes across all study phases, including site evaluation, TMF maintenance, and regulatory submissions
- Supervised and coordinated clinical trial monitoring activities, ensuring adherence to Good Clinical Practice (GCP) guidelines
- Conducted risk-based monitoring and issue resolution, utilizing data analytics to identify trends and mitigate potential study risks
- Directly managed a team of 10 Clinical Trial Coordinators, overseeing project timelines, deliverables, and regulatory compliance
- Ensured audit readiness and compliance with 21 CFR Part 11, facilitating successful sponsor audits and regulatory inspections
Clinical Project Coordinator (CPC)
Imaging Endpoints Pvt Ltd.
Hyderabad
12.2021 - 01.2023
- Specialized in data validation and discrepancy resolution, ensuring high-quality and audit-ready datasets
- Oversaw database lock, interim analyses, and data transfer, supporting critical study milestones
- Developed query management processes, reducing resolution timelines and improving data integrity
- Oversaw clinical database reconciliation, validation, and discrepancy management, ensuring consistency and completeness of study data
- Performed site data verification and source document review to ensure protocol adherence and data integrity
- Executed query resolution and discrepancy management strategies, working with sites and sponsors to maintain high-quality datasets
- Managed study documentation, including Data Clarification Forms (DCFs), electronic case report forms (eCRFs), and risk logs
- Collaborated with data management teams to support database lock, interim analyses, and final data transfer for regulatory submissions
- Facilitated training sessions on CDMS (Clinical Data Management Systems) for new team members, enhancing process efficiency
Dental Surgeon
Shambala Dental Spa and Wholeness
Hyderabad
06.2016 - 08.2021
- Led clinical operations and patient management, ensuring efficient workflow and high-quality patient care
- Implemented Electronic Health Records (EHR) and digital patient tracking, enhancing documentation accuracy and regulatory compliance
- Conducted evidence-based diagnostic assessments using advanced imaging technologies, aligning with clinical trial methodologies
- Developed and standardized treatment protocols, improving patient outcomes and streamlining healthcare delivery
- Led public health initiatives, organizing workshops and awareness programs on preventive healthcare and early disease detection
- Developed and optimized patient data tracking systems, ensuring compliance with HIPAA and other regulatory standards
- Designed digital treatment planning protocols utilizing imaging technologies for accurate diagnosis and treatment execution
- Led public health awareness programs, promoting preventive care and early detection strategies
Dental Surgeon
Tooth First Dental Clinic
Hyderabad
11.2014 - 05.2016
- Performed complex diagnostic evaluations utilizing radiographic imaging and clinical assessments, ensuring precision in treatment planning
- Specialized in minimally invasive and advanced restorative procedures, including laser-assisted treatments, root canals, and prosthodontic restorations
- Integrated digital health solutions into clinical workflows, improving patient monitoring and data-driven decision-making
- Collaborated with multidisciplinary teams, contributing to patient case discussions and optimizing treatment approaches
- Developed SOPs for infection control and clinical safety, ensuring compliance with healthcare regulations and patient safety standards
- Conducted comprehensive diagnostic assessments using radiographic imaging and advanced scanning technologies
- Executed precision-based restorative procedures, including single/multi-sitting root canals, crowns, and bridges
- Integrated digital dental workflows to enhance patient outcomes and optimize practice efficiency
- Developed digital patient records and implemented automated appointment scheduling systems
Medical Officer
Care Hospitals
Hyderabad
08.2013 - 10.2014
- Managed emergency response and acute care interventions, ensuring rapid assessment and treatment of critical patients
- Conducted preoperative and postoperative evaluations, coordinating with surgical teams for oncology and trauma cases
- Led clinical documentation and case management, ensuring accuracy in medical records and compliance with hospital accreditation standards
- Implemented digital pathology reporting workflows, enhancing diagnostic accuracy and efficiency in patient management
- Participated in clinical research and patient data analysis, contributing insights for protocol development and evidence-based practice
- Managed emergency care interventions and acute medical case documentation using electronic medical record (EMR) systems
- Performed minor surgical procedures and assisted in major oncological surgeries, leveraging clinical imaging technologies for precision
- Integrated digital pathology reporting into clinical workflows, improving diagnostic efficiency
- Ensured compliance with hospital accreditation standards and regulatory policies
Intern
Karpaga Vinayaga Institute of Dental Sciences
Tamil Nadu
08.2011 - 12.2012
- Completed rotations in advanced dental specialties, gaining hands-on experience with surgical and prosthetic procedures
- Implemented digital imaging workflows for diagnosis and treatment planning
- Conducted case studies and research on emerging dental technologies
Education
Bachelor of Dental Surgery (BDS) -
Dr. M.G.R Medical University
ChennaiAdvanced Diploma in Clinical Research & Data Management -
ICBio Clinical Research Pvt Ltd
BengaluruData Management for Clinical Research - Online
Vanderbilt University
Design & Interpretation of Clinical Trials - Online
Vanderbilt University
Medical Writing for Healthcare Professionals -
Udemy Certification
Skills
- Clinical Trial Management
- Study Conduct Oversight
- Clinical Data Management
- Database Validation
- Oncology Trials
- ESource
- EDC System Configuration
- Risk-Based Monitoring
- Issue Resolution
- Data Validation
- Query Resolution
- Discrepancy Management
- Site Management
- Vendor Management
- Regulatory Compliance
- Stakeholder Engagement
- Client Communication
- Audit Preparation
- Quality Assurance
- Decentralized Clinical Trials
- ECOA Implementation
- CTMS
- Data standardization
- eCRF design
- User acceptance testing
- Regulatory compliance
- Clinical data management
- Project management
- Process improvement
- Attention to detail
- Configuration management
- CDMS
- MS Excel
- Data Analytics
- Medical Imaging
- Digital Health Technologies
- Advanced Documentation
- Regulatory Submission Preparation
- Clinical trial management
- Data integrity
- Quality control
- Project evaluation
- Audit readiness
- Meeting facilitation
- Project planning
- Training and mentoring
- Collaborative mindset
- Project feedback data
- Deadline adherence
- Time management
- Risk analysis and management
Timeline
Source Configuration Specialist
OneStudyTeam - Reify Health
01.2024 - Current
Manager, Clinical Operations
Imaging Endpoints Pvt Ltd.
01.2023 - 10.2023
Clinical Project Coordinator (CPC)
Imaging Endpoints Pvt Ltd.
12.2021 - 01.2023
Dental Surgeon
Shambala Dental Spa and Wholeness
06.2016 - 08.2021
Dental Surgeon
Tooth First Dental Clinic
11.2014 - 05.2016
Medical Officer
Care Hospitals
08.2013 - 10.2014
Intern
Karpaga Vinayaga Institute of Dental Sciences
08.2011 - 12.2012
Bachelor of Dental Surgery (BDS) -
Dr. M.G.R Medical University
Advanced Diploma in Clinical Research & Data Management -
ICBio Clinical Research Pvt Ltd
Data Management for Clinical Research - Online
Vanderbilt University
Design & Interpretation of Clinical Trials - Online
Vanderbilt University
Medical Writing for Healthcare Professionals -
Udemy Certification
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