Srihitha k
Jersey City
Summary
Clinical Data Analyst with significant experience at Icon, specializing in data management and regulatory compliance. Expertise in SAS and SQL, leading to enhanced process efficiencies and audit-ready datasets. Strong collaborator and mentor, consistently achieving high-quality outcomes in dynamic environments.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Data Analyst III
Icon
05.2024 - Current
- Lead clinical data management for global Phase I–IV studies across multiple indications, ensuring high-quality, audit-ready data compliant with protocols and regulations.
- Prepare and review trial documents including protocols, CRF designs, edit check specs, completion guidelines, and Data Management Plans focused on data integrity.
- Develop, validate, and execute edit checks and UAT scripts in Medidata Rave and Oracle Clinical; document and resolve validation issues.
- Manage end-to-end data cleaning, discrepancy resolution, query management, and real-time tracker updates.
- Perform external data reconciliation (SAE, labs, ECG) with vendors, maintaining logs and resolving inconsistencies.
- Collaborate with SAS/SQL programmers to QC data listings, metrics, and reports for ongoing review.
- Maintain inspection-ready documentation in eTMF per ICH-GCP, FDA 21 CFR Part 11, CDISC/CDASH, and SOPs.
- Represent data management in cross-functional meetings to align on study timelines and deliverables.
- Support database lock and study close-out, ensuring clean datasets and thorough documentation.
- Mentor junior staff by developing training materials and process documentation for Oracle Clinical and other systems.
- Ensure consistent medical coding using MedDRA and WHO-DD; perform QC on coding trackers and documents.
- Drive process improvements by identifying inefficiencies, proposing solutions, and supporting SOP/training updates.
- Utilize SAS and SQL knowledge to assist data review, troubleshooting, and communication with programming teams.
Clinical Data Analyst II
PPD
Hyderabad
12.2021 - 09.2022
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
- Performed Database freezing and locking within the studies and ensure all the data get locked by doing QC/peer review.
- Performs data management activities such as Serious Adverse Events and Third-Party Vendor reconciliations.
- Experience in working on EDC including Medidata Rave and Oracle.
- Involved in creating Edit Checks/Query Logic and User Acceptance Testing (UAT).
- Have good experience in reviewing and giving inputs for all study-related documents (CRF specifications and DVM).
- Allocated and monitored query resolutions among team members daily, ensuring efficient task distribution and timely completion.
- Trained extensively in Oracle Clinical, gaining in-depth knowledge of its functionalities to optimize clinical data management processes.
Clinical Data Analyst I
ClinzeTech
Hyderabad
12.2019 - 12.2021
- Extracted clinical trial data from EMRs and paper CRFs, ensuring accurate entry into EDC systems per protocol and regulatory requirements.
- Managed all data and project activities from study start-up to database lock.
Investigation Management Solutions Specialist
Syneos Health
09.2018 - 10.2019
- Reviewed and provided input for research protocols, CRF designs, and completion guidelines.
- Acted as a liaison between clinical sites, research teams, project managers, and stakeholders for smooth project execution.
- Utilized Medidata CTMS for site activation, setup, and managing investigator contract/budget data.
- Ensured timely and accurate completion of site activation processes in CTMS.
- Managed entry, validation, and maintenance of investigator contract and budget information.
- Validated grant payment requests via CTMS, verifying EDC data and ensuring SDV compliance.
- Reviewed and interrogated CTAs and amendments for accurate payment processing.
- Collaborated with site staff and clinical teams to resolve payment issues, discrepancies, and overdue invoices.
- Participated in Subject Visit Design Meetings to optimize trial processes.
Clinical Research Coordinator
Surakshaka Hospitals
12.2017 - 09.2018
- Managed subject screening, informed consent, source data collection, and paper-based CRF data entry.
- Extracted clinical trial data from patient files and lab reports to complete paper CRFs accurately.
- Reported AEs/SAEs and collaborated with investigators for accurate documentation and resolution.
- Supported site monitoring visits, maintained essential regulatory documents, and addressed audit queries.
- Coordinated with lab and clinical teams to resolve discrepancies in source documentation.
Education
Master of Science - Information Technology
University of the Cumberland's
KY, USA05.2024
Pharma D - Doctor Of Pharmacy -
Acharya Nagarjuna University
India01.2017
Skills
- Medical terminology and anatomy knowledge
- Database management and query resolution
- Clinical trial management systems
- Data validation and verification
- Regulatory compliance and protocol adherence
- CRF design and tracking
- Custom data listings and clinical reporting
- SAS and SQL proficiency
- Time management and discrepancy resolution
- Clinical data management
- Medidata Rave expertise
- Edit check development
- Regulatory knowledge
- Database locking
- Vendor reconciliation
- Cross-functional collaboration
- Project coordination
- Problem solving
- Team mentoring
Certification
- Good Clinical Practice - ICH E6(R2), Clinical Research Fastrack — 2024-11
- CITI Program Certification – Completed, Certified Clinical Data Manager (CCDM) — In progress
Training
- Clinical Research Training covering Core Competencies including:
- ICH GCP E6 R (2)
- FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46
- Data Management
- Informed Consent Process
- Clinical Trial Operations from feasibility through close-out
- GDP following ALCOA-C principles
- Identification and reporting of AEs and SAEs
- Quality Assurance, Monitoring, and Query Resolution
- Comprehension and Execution of Clinical Trial Protocols
Timeline
Clinical Data Analyst III
Icon
05.2024 - Current
Clinical Data Analyst II
PPD
12.2021 - 09.2022
Clinical Data Analyst I
ClinzeTech
12.2019 - 12.2021
Investigation Management Solutions Specialist
Syneos Health
09.2018 - 10.2019
Clinical Research Coordinator
Surakshaka Hospitals
12.2017 - 09.2018
Master of Science - Information Technology
University of the Cumberland's
Pharma D - Doctor Of Pharmacy -
Acharya Nagarjuna University
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