Sruthi Reddy
Northlake,TX
Summary
- 6+ years of experience in Clinical Data Management across study start-up, conduct, and closeout activities, with expertise in early development, safety and efficacy, and late-phase clinical trials. Proven ability to collaborate with CROs and pharmaceutical organizations.
- Skilled in eCRF design, edit checks, User Acceptance Testing (UAT), Lab and external vendor data reconciliation, data cleaning, and query management. Proficient in both Paper and EDC trials, with extensive use of Oracle Clinical, Oracle InForm, and Medidata Rave.
- In-depth knowledge of ICH-GCP, GCDMP, 21 CFR Part 11, CDISC, CDASH standards, and creating Data Management Plans (DMPs) in compliance with SOPs, GCP, and regulatory guidelines. Experienced in medical coding using MedDRA and WHODD.
- Strong leadership skills with experience in team management, vendor management, and client communication. Successfully mentored junior staff to deliver high-quality, clean datasets on time and manage multiple projects simultaneously.
- Well-organized, quick learner with a keen eye for detail, strong communication skills, and the ability to adapt and manage complex responsibilities. Therapeutic area experience includes Cardiovascular, CNS, Immunology, Oncology, Vaccines, and Respiratory diseases.
Overview
10
10
years of professional experience
Work History
Clinical Data Manager
Parexel
05.2023 - 06.2024
- Developed data validation specifications, edit checks, test scripts, and data management plans to ensure data accuracy.
- Collaborated with cross-functional teams (Clinical Operations, Safety Surveillance, Regulatory Affairs, Biostatistics) to address study-related issues.
- Managed study setup, conduct, and database lockout activities within Clinical Data Management (CDM).
- Designed eCRFs and annotated CRFs based on protocol specifications and CDASH requirements.
- Conducted SAE reconciliation and analyzed data through listings and automated queries.
- Created edit check documentation and contributed to the development of study-specific documents such as eCRF Completion Guidelines, Data Management Plans (DMP), and SOPs.
- Ensured compliance with ICH-GCP, FDA, and IRB regulations.
- Created clinical database specifications, including eCRF design, user requirements, query logic, and data validation protocols.
- Monitored study progress through metrics to ensure adherence to timelines and quality standards.
- Provided input for operational improvements, optimizing workflows while maintaining quality.
- Mentored new team members and provided training on data management workflows.
- Managed database freezes and locks for statistical review and final database lock.
Clinical Data Manager
OPIS
10.2022 - 03.2023
- Reviewed clinical research study protocols and developed Data Management Plans (DMPs) in collaboration with internal and external teams.
- Worked closely with database developers to design, test, and implement study databases.
- Actively participated in testing various Edit Checks during User Acceptance Testing (UAT) and system testing.
- Identified discrepancies, issued queries, tracked responses, and incorporated query replies.
- Validated data in accordance with the Data Validation Plan and Data Management Plan to ensure database consistency and accuracy.
- Generated electronic queries to internal or external personnel (e.g., investigational sites, Clinical Research Associates) to resolve data issues.
- Performed soft and hard locks of the database upon study completion after thorough data QC.
- Served as the point of contact for external vendors to resolve issues related to lab data loading (PK, PD & Biomarker).
- Ensured data entry, transfer, and processing were compliant with ICH, GCP, and CDISC regulatory guidelines.
Clinical Data Manager
ICON
03.2020 - 09.2022
- Reconciled SAEs, ensuring compliance and data accuracy.
- Managed discrepancies through both automated and manual processes.
- Reviewed data via listings and auto queries for consistency.
- Developed edit check documents based on study protocols.
- Generated queries for incomplete, unclear, or discrepant data, aligned with the Data Management Plan (DMP).
- Developed and tested databases and edit specifications to ensure accurate data management.
- Ensured adherence to study protocols, SOPs, ICH GCP, and industry guidelines.
- Led specific areas/processes in large studies with minimal supervision.
- Served as backup for Data Operations Coordinators and Data Team Leads.
- Provided feedback to programming teams on listings and edits.
- Analyzed and mapped site data trends for the clinical team.
- Managed CSSRS data across four studies, ensuring completeness and accuracy.
- Cleaned CM and CMRA data for extension studies.
- Conducted manual CRF data and data-dump listing reviews.
- Managed data activities for Phase 2 & 3 clinical trials, from setup to conduct.
- Contributed to study closeout activities, ensuring timely completion.
- Tracked clinical study progress, ensuring alignment with timelines and requirements.
Clinical Data Cordinator
UBC
09.2018 - 01.2020
- Managed data review, discrepancy management, listing reviews, and quality control, while providing status reports to the client.
- Generated and reviewed EDC/UAT functionality, ensuring comprehensiveness and accuracy of edit checks.
- Assisted in developing case report forms (CRFs) and CRF completion guidelines/specifications.
- Collaborated with the Clinical Data Manager on manual data reviews and database lock activities (soft/hard).
- Generated Data Clarification Forms (DCFs) for incomplete, unclear, or discrepant data per the Data Management Plan (DMP).
- Performed weekly tasks including SAS listing reviews, IVRS and lab reconciliation, SAE reconciliation, and documentation.
- Conducted Database User Acceptance Testing (UAT) and Edit Check UAT for assigned studies.
- Updated communication logs with UAT findings and coordinated follow-up with the database development team.
- Managed discrepancy resolution, raised DCFs, and updated communication logs and trackers.
Clinical Data Cordinator
Iqvia
07.2014 - 02.2015
- Managed project timelines, reviewed clinical research protocols, and assisted in the development of case report forms and CRF guidelines.
- Supported study set-up, validation, and implementation of clinical databases, while tracking data management progress for allocated trials.
- Reviewed clinical data, resolved discrepancies, and generated queries in clinical databases, ensuring comprehensive EDC/UAT functionality and edit checks.
- Coordinated with internal/external teams, representing data management and fine-tuning DM processes in collaboration with global colleagues.
- Contributed to company task forces and initiatives, and liaised with cross-functional teams (monitoring, programming, medical coding, and statistics) to ensure smooth study execution.
Education
Master of Science - Pharmaceutical Analysis And Quality Assurance
Jawaharlal Nehru Technological University
India01-2014
Bachelor of Science - Pharmacy
Kakatiya University
India01-2011
Skills
Data Analysis, UAT execution, SAE reconciliation, Data locking, INFORM, Clintrial, CDISC, DCF, eCRF design, Discrepancy Management, External vendor data reconciliation, 21CFR part 11, Medidata Rave, Oracle Clinical, GCP, SEC
Computer skills: Microsoft Office Suite (MS) Word, Excel, PowerPoint, Outlook and HPLC software packages like Chem-station, total Chrome, and Empower
Timeline
Clinical Data Manager
Parexel
05.2023 - 06.2024
Clinical Data Manager
OPIS
10.2022 - 03.2023
Clinical Data Manager
ICON
03.2020 - 09.2022
Clinical Data Cordinator
UBC
09.2018 - 01.2020
Clinical Data Cordinator
Iqvia
07.2014 - 02.2015
Master of Science - Pharmaceutical Analysis And Quality Assurance
Jawaharlal Nehru Technological University
Bachelor of Science - Pharmacy
Kakatiya University
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