Hasika K
Clinical Data Manager
Summary
- Highly analytical and results-oriented professional experienced in managing multiple clinical trials (Phase 1-3) with cross-functional teams and external vendors.
- Possesses extensive knowledge of database management across all phases of clinical data management, including startup, conduct, and lock phases.
With over 4 years of experience as a clinical data manager, responsible for overseeing all data management deliverables from protocol concept review to completion of the clinical study report. - Proficient in working with various EDC databases such as Medidata Rave, Veeva Vault, Medrio and Clinion. Collaborated on numerous projects spanning different phases and therapeutic areas including Oncology, Neurology, Hematology, Rare diseases/Immunology, Respiratory Diseases, and GI disorders.
- Provided feedback to the clinical team during Clinical Protocol Review to ensure accurate database design. Managed and coordinated study start-up activities including eCRF design and implementation within an EDC system, adhering to study-specific guidelines.
- Expertise in developing Data Validation Specifications, conducting live activities, and testing/accepting clinical databases for EDC studies. Proficient in creating User Acceptance Testing (UAT), Edit Checks, and Query Logics prior to Go live.
- Experienced in developing Data Transfer Agreements (DTA) with external vendors and preparing study startup documents such as Data Management Plan (DMP) and CRF Completion Guidelines (eCCG's), while implementing data management standard operating procedures (SOPs).
- Effectively managed Post-Production Change (PPC) deployments/migrations, collaborating with key client stakeholders and supporting eCOA/ePRO, IRT to ensure successful implementation.
- Managed reconciliation with external vendor data including SAE, IRT, and Lab Reconciliation (Local and Central labs) during study conduct. Conducted Reconciliations and Discrepancy/Query Management by providing timely reporting of outstanding queries and CRFs to ensure smooth data collection.
- Experienced in executing Interim Analysis and Study Closure Activities to ensure a valid interface with the study team, including freezing for final database lock/hard locks.
Overview
5
5
years of professional experience
4
4
Certifications
Work History
Graduate Research Assistant
Southern University And A&m College - Baton Rouge La
08.2021 - 08.2023
- Conducted thematic analysis of qualitative data from focus groups, extracting key themes and insights to improve the services of Louisiana Rehabilitation Services.
- Worked on Project E3, contributing to research activities and assisting in data analysis using SPSS and Microsoft Excel.
- Developed and generated surveys for research studies using Survey Monkey, ensuring survey validity and reliability.
- Assisted in grant writing, contributing to the development of research proposals and funding applications on Campus related to Rehabilitation and Disability Studies.
- Collaborated with research team members from the Department of Computer Science in designing and implementing data collection protocols about Post Covid Consequences and it’s management.
- Familiar in data management, including data cleaning, organization, and storage in the projects using OpenClinica.
- Assisted in participant recruitment and scheduling for research studies within the Department about Impression Management, Job Interviewing and Training for college students with disabilities.
- Conducted literature reviews and synthesized relevant research findings to inform research projects.
- Played an active role in data visualization, utilizing basic charting and graphing features in Microsoft Excel to create visual representations of research findings.
- Contributed to writing and editing of research reports, manuscripts, Microsoft word documents and PowerPoint presentations.
Clinical Data Manager
Pfizer
, PA
01.2020 - 08.2021
- Proficient in analyzing and comprehending protocols for clinical studies, providing feedback to the clinical team during Protocol Review.
- Skilled in designing eCRFs, coordinating live database activities, and conducting thorough testing and acceptance of clinical databases (UAT) for EDC studies during the study startup phase.
- Responsible for developing test scripts and test plans, and conducting UAT for new study databases.
- Participated in writing and reviewing eCRF Completion Guidelines and executed activities outlined in the Data Management Plan for all phases of clinical trials.
- Created Data Validation Specifications (DVS) to ensure robust edit check programming and testing of clinical databases.
- Assisted in creating Data Transfer Agreements (DTA) and Data Transfer Standards (DTS) with external vendors, ensuring data was transferred according to specifications.
- Participated in client interaction meetings and managed relationships with external vendors.
- Handled external data reconciliations including lab reconciliations (local and central labs) and reconciliations for third-party vendor data such as ECG, PK, and SAE.
- Actively participated in study debrief meetings, implemented and reviewed reports and listings to maintain data integrity standards.
- Verified reports created in EDC or other ad-hoc reporting tools and managed associated change control requests.
- Collaborated closely with programmers to create, review, and validate DVS/ECS (edit check specifications) and performed Discrepancy Management and Query Logics.
- Ensured timely data cleaning according to the Data Review Plan across projects.
- Participated in the implementation of eCOA/ePRO systems for global clinical trials, ensuring regulatory compliance.
- Initiated and maintained documentation for data management project files, tracking and reporting data management activity status including milestones and timelines.
- Assisted in QC of databases using SAS listings against the CRF and resolved queries to establish a clean database.
- Managed study closing activities such as last round DTA, Query Management, Source Data Verification (SDV), data freezing, and Study Lock.
- Executed data freezing and locking as appropriate in time for Interim Analysis, statistical review, and final database lock.
- Assisted in developing and maintaining DM standards and processes in accordance with applicable SOPs and GCPs.
Clinical Data Associate
Abiogenesis
05.2018 - 12.2019
- Assisted in reviewing clinical research study Protocol and developing Case Report Forms, eCCGs and annotated case report forms.
- Participated in study start-up, validation, and implementation of clinical databases.
- Prioritized project objectives reported and communicated project status; metrics as defined in the communication plan.
- Participated in developing project documents like Data Management Plan (DMP) and Data Transfer Agreements (DTA).
- Developed study documents like Data Validation Plan and Data Entry Guidelines (CCGs).
- Assisted in creating edit check specification and perform User Acceptance Testing (UAT) of configured databases.
- Worked extensively during study conduct on validating the data by Discrepancy Management, performing external Vendor Reconciliations like Lab, SAE (Aris Global), IRT.
- Performed the out-of-range checks for Lab data and Quality Check of the data by Manual Review/ J-Review.
- Ensured that appropriate timelines are met along with the goals and objectives by maintaining proper documentation and records of data
- entry activities, including log sheets, progress reports, and audit trails.
- Assisted in performing clinical data Interim analysis.
- Performed lock activities of the database at the completion of the study.
- Strong knowledge and commitment of adherence to ICH-GCP, SOPs and IRB regulations.
- Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on various electronic data capture tools.
- Maintained good communication and working relationships with cross functional leads.
- Participated in team projects, demonstrating ability to work collaboratively and effectively.
Education
Doctor of Pharmacy -
Jawaharlal Nehru Technological University
Hyderabad TS-IN 05.2001 -
Master of Science - Rehabilitation Science
Southern University And A & M College
Baton Rouge, LA 05.2001 -
Skills
Tools: J-Review, Spotfire, Elluminate
Therapeutic Areas
- Oncology
- Neurology
- Nephrology
- General Medicine
- Dermatology
- Gastroenterology
Certification
Certified in Data Management for Clinical Research
EDC Systems
- Medidata Rave
- Medrio
- Veeva Vault
- Clinion
Timeline
Graduate Research Assistant
Southern University And A&m College - Baton Rouge La
08.2021 - 08.2023
Clinical Data Manager
Pfizer
01.2020 - 08.2021
Clinical Data Associate
Abiogenesis
05.2018 - 12.2019
Doctor of Pharmacy -
Jawaharlal Nehru Technological University
05.2001 -
Master of Science - Rehabilitation Science
Southern University And A & M College
05.2001 -
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