Yusra Swati
Shrewsbury,MA
Summary
Experienced Data Manager with 18+ months of experience in Clinical Research. Exceptional skills in planning, analyzing, and accomplishing diverse responsibilities for Clinical Data Management (CDM) activities. Outstanding knowledge of industry guidelines including ICH GCP, 21 CFR part 11, GCDMP, and US FDA safety reporting. Well-versed in CDISC guidelines, SDTM, CDASH, and Medical Coding standards such as MedDRA and WHO Drug. Proficient in managing multiple clinical trials from phase I to phase IV. Successfully trained newly hired data management personnel and efficiently managed Study start-up, conduct, and close-out activities. Expertise in Vendor management, Local lab, and Third-party lab data review and reconciliations. Extensive training in Medidata Rave, RaveX, Rave Classic, and Trial Management EDCs. Strong interpersonal and communication skills. Established successful relationships with colleagues and cross-functional teams, and demonstrated leadership for process improvements.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Data Manager
Iovance Biotherapeutics
05.2022 - 11.2023
- Lead Data Management point of contact for closeout study on day-to-day activities with key responsibilities for study lock tasks.
- Worked on various oncology therapeutic areas in all Phases from study startup to close out.
- Assisted in updating data management Standard Operating Procedures (SOPs), Protocol Amendments, CRF design, Edit Checks, SDTM, IRRS Specifications, Dossier Specifications, and CRF completion guidelines through the change control process as needed.
- Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools.
- Ensured the studies were conducted as per the SOPs, ICH GCP, protocol requirements, and standard guidelines.
- Maintained project documents like Data validation Plan DVP, Data Management plans (DMP), CRF completion guidelines (CCGs), Data Transfer Agreements (DTA) & Departmental SOPs, Change Control Log CCL, and Site Closure Checklist and provided input on study designs.
- Worked closely with project-specific Lead Data Managers on the Database design, Database upgrades/migrations, Data Listings, Lock/Unlock activities, Smart Listings, COVID-19 tracker, and Subject Status Tracker and performed Edit checks & User Acceptance Testing UAT.
- Generated study-specific reports, ad hoc reports for Overall Survival Follow-up, AE grade change, Image Read Ready Report IRRS, Finance reports, CSR reports, Patient Tracker, and Metrics to track the status of the study.
- Performed Serious Adverse Events SAE reconciliation and external vendor lab data reconciliation including but not limited to Immune Monitoring, Image, Blood/Tissue/HLA samples for several clinical trials following company-based work instructions.
- Resolved Data Discrepancies, Site Queries, Query Generation & Resolution, and related issues through the implementation of robust validation checks and error resolution procedures.
- Contributed towards developing guidelines/checklist that aids in streamlining activities for Data Management (DM) during phases 1-4.
- Facilitated Study team meetings, monitored weekly schedules, and confirmed the accuracy and reliability of data.
- Trained clinical team on project specifics, and ensured appropriate distribution of work.
- Implemented solutions to issues that arose during the development, management, and close-out of clinical studies.
- Map the data trends concerning the site and provide them to the clinical team.
- Collaborated and coordinated with a team of data managers for all the data management activities, and ensured appropriate distribution of work.
- Worked with Medical Monitors, Database Programmers, Clinical Operations, Bio Statisticians, and external Vendor teams to ensure the smooth functioning of studies.
- Tracked status and progress of data management for allocated projects/trials.
- Ensured accurate coding of medical terms using MedDRA or WHO-DD dictionaries, facilitating standardized reporting across studies.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
- Supported the implementation of new technologies and software tools to enhance data management capabilities and minimized manual system errors with a streamlined data entry process.
- Optimized database structures for efficient data storage, retrieval, and analysis capabilities.
- Assisted in the preparation of regulatory submissions by generating high-quality datasets and relevant documentation.
- Safeguarded patient confidentiality by enforcing strict adherence to HIPAA regulations and company policies.
- Provided training and mentorship to new staff members, fostering professional growth and skills development.
- Conducted ongoing assessments for Data Cleaning throughout the course of each trial, addressing any issues promptly and effectively.
- Participated in quality check reviews to verify accuracy and reliability of data.
Education
Bachelors in Computer Application -
University of Madras
Chennai, India 12.2023 - 05.2024
Skills
- Medidata RAVE EDC
- RaveX
- Rave Classic
- Rave RTSM
- Trial Master EDC
- Spotfire Analytics
- SharePoint
- Clinical Data Management CDM
- Data Review Plan DRP
- Data Management Plan DMP
- CRF Completion Guideline CCG
- GCP
- SAE Reconciliation
- ECRF design
- Data Validation Techniques DVT
- CDISC
- Regulatory compliance
- UAT
- QC
- MS Excel
- MS Office
- MS Project
- Data Cleaning
- Data reporting
- Effective Time Management
- Strong Communication
- Training and mentoring
- Conflict Resolution
- Teamwork and Collaboration
- Attention to Detail
- Vendor Management
- Multitasking Abilities
- Organizational Skills
- Relationship Building
Personal Information
Title: Lead Data Manager
Certification
Certified Data Management for Clinical Research, Vanderbilt University - May 2024
Languages
Urdu
Native or Bilingual
Tamil
Elementary
Hindi
Limited Working
Arabic
Elementary
Timeline
Bachelors in Computer Application -
University of Madras
12.2023 - 05.2024
Clinical Data Manager
Iovance Biotherapeutics
05.2022 - 11.2023
Certified Data Management for Clinical Research, Vanderbilt University - May 2024
Similar Profiles
Cyril PossaCyril Possa
Executive Director of QA Technical Services at Iovance BiotherapeuticsExecutive Director of QA Technical Services at Iovance Biotherapeutics
Eilidh PurkissEilidh Purkiss
Human Resources Intern at Iovance BiotherapeuticsHuman Resources Intern at Iovance Biotherapeutics
Alliyah ArgiroAlliyah Argiro
Aseptic Manufacturing Technician II at Iovance BiotherapeuticsAseptic Manufacturing Technician II at Iovance Biotherapeutics