Mohseena Begum S
Bangalore
Summary
Dynamic Clinical Data Manager with extensive experience at Fortrea, excelling in data management and analysis. Proven track record in enhancing data integrity through effective query resolution and user acceptance testing. Adept at project coordination, ensuring timely delivery of quality data while mentoring teams to uphold high standards.
Overview
10
10
years of professional experience
Work History
Associate Clinical Data Manager
Fortrea (Formerly Labcorp)
Bangalore
04.2023 - Current
- Collaborated with Lead DM (LDM) on studies involving healthy and patient populations across multi-site, medium complexity protocols, ensuring effective communication and project alignment.
- Performed all data operational tasks, including data review and query management, to achieve quality standards for both internal and sponsor requirements.
- Worked with LDM to develop study milestone timelines, demonstrating ability to interpret and adhere to timelines while providing informed suggestions for adjustments based on study design.
- Assist or lead to write, update/review and approve all required trial data management documentation, including but not limited to: Study-specific case report forms, CRF Completion Guidelines, Data Management Plan, Data Quality Checks (edit checks)
- Assist or lead the internal and external Data Management meetings
- Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts)
- Ensuring study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study
- Track scope changes and work with the Lead DM to ensure that Sponsor approval is received, and the scope change processed
- Supports the training of new staff on project specific Data Management processes. Ensures service and quality meet agreed upon specifications per the DMP and scope of work
- Coordinate with DM study team to ensure the receipt and inventory of all data related information is delivered within agreed upon timelines
- Perform User Acceptance Testing (UAT) of report outputs to ensure accuracy, quality, and compliance with study requirements.
- Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained. Provide feedback constructively on relevant issues and initiate process review as appropriate
- Ensure all appropriate documentation and procedures are performed upon project completion for operations team. Assist or lead the managing of the DM study team to ensure client satisfaction is achieved through delivery of quality data
- Assist or lead with the completion of Database Lock and Unlock activities with LDM
- Assist or provide reports to Sponsor and internal team as dictated by project need
- Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team
- Provide guidance and support to the team in updating Lab Normal Ranges (LNR) in EDC, including initial QC and final QC against source documents.
- Proactively follow up with internal and external stakeholders to ensure timely resolution of LNR-related issues.
- Organize and facilitate regular meetings with both internal and external teams to discuss outstanding issues, drive resolutions, and ensure adherence to project timelines and quality standards.
- Collaborate closely with programmers to develop study-specific reports by preparing clear and comprehensive programming specifications.
- Review and validate report metrics to support efficient data review, trend analysis, and timely identification of data issues.
- Enhanced reporting processes to streamline data review activities, supporting improved study oversight and operational efficiency.
Senior Clinical Data Specialist
Fortrea (Formerly Labcorp)
Bangalore
11.2021 - 03.2023
- Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation
- Generate, resolve, and track queries to address problematic data identified during data review activities
- Maintain and exceed the organizational set guideline of utilization to achieve >90% utilization
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
- Mentored and coached project staff on data management processes and trained them on project-specific, global, standardized data management practices
- Performed quality control on data management activities, including all study documentation and query generation.
- Apply quality control procedures and checks to ensure data quality standards are achieved. Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans.
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
- Created and assisted in developing data review guidelines to ensure consistency with clinical data model and CRF/eCRF completion monitoring conventions
- Supported and resolved issues from client or internal audits within established timelines, addressing client comments with study team as needed
Clinical Data Specialist
Labcorp (Formerly Covance)
Bangalore
06.2018 - 10.2021
- Generate, resolve, and track queries to address problematic data identified during aggregate data review activities
- Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data
- Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data
- Generate and QCs data listings for internal data review
- Collaborated with project team members to facilitate set-up, maintenance, and closure of data management aspects, actively participating in project meetings
- Demonstrates the ability to review Edit Check Specifications and Database specifications.
- Generated study status reports for review prior to Sponsor meetings in preparation for Sponsor meetings and to deliver on specific Sponsor request
- Assist with the completion of Database Lock and Unlock activities
- Trained new staff on project-specific data management processes to enhance team readiness and consistency
Clinical Data Specialist
Covance (Formerly Chiltern)
Bangalore
07.2018 - 06.2019
- Reviewed reports and executed actions per DMP or eCRF review manual to ensure data integrity
- Provided listings for study teams per DMP and addressed discrepancies to maintain data accuracy
- Conducted ongoing and final consistency checks, reviewed protocol deviations and data listings per DMP and eCRF review manual to uphold compliance
- Performed UAT according to Validation Plan for Data Management systems
- Maintain Data Management related operational data flows
- Review and action queries on an ongoing basis and update database appropriately
- Perform updates post database lock if any
Clinical Data Analyst-Intern
Chiltern Clinical research organization
Bangalore
02.2017 - 06.2018
- Generated, resolved, and tracked queries to address problematic data identified during aggregate data reviews, enhancing data integrity
- Performed all data management tasks, including data review and query management, to ensure quality standards were met within stipulated timelines.
- Developed edit check specifications and data review guidelines, raising queries to resolve erroneous, missing, or incomplete data
- Run and execute additional programs, special listings, reconciliation discrepancy listings etc.) used to support the review of clinical trial data
- Interacted with project team members to support the set-up, maintenance, and closure of Data Management aspects of the project.
- Created dummy data to test edit checks, database screen design, functionality, and SAS reports, ensuring accuracy in data listings
- Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines
- Assist with the completion of Database Lock activities
- Support the training of new staff on project specific Data Management processes
Education
Bachelor of Science (B. Sc) - Biotechnology
M.E.S College of Arts Commerce and science
Bangalore, Karnataka, IndiaMaster of Science (M. Sc) - Biotechnology
Government Science college
Bangalore, Karnataka, IndiaSkills
- Clinical data analysis
- Data management
- Database validation
- Data management plan
- User acceptance testing
- Query resolution
- Project coordination
Language Capabilities
ILR 3 (Professional Working Proficiency), ILR 5 (Native or Bilingual), ILR 5 (Native or Bilingual)
Memberships Awards
- Client Excellence, 2022
- Covance, Clinical Data Specialist, 2022
Systems Experience
6, 4, 2, 4, 1
Therapeutic Experience
- Oncology: Advance Solid Tumors - Lymphoma (Phase I)
- Oncology: Advanced Metastatic Solid Tumors- Breast Cancer (Phase IIb)
- Oncology: Ovarian Cancer (Phase III)
- Cardiovascular: Acute Coronary Syndrome - Hypertension (Phase IIIb)
- Oncology: Pan Tumor-(Phase II)
Timeline
Associate Clinical Data Manager
Fortrea (Formerly Labcorp)
04.2023 - Current
Senior Clinical Data Specialist
Fortrea (Formerly Labcorp)
11.2021 - 03.2023
Clinical Data Specialist
Covance (Formerly Chiltern)
07.2018 - 06.2019
Clinical Data Specialist
Labcorp (Formerly Covance)
06.2018 - 10.2021
Clinical Data Analyst-Intern
Chiltern Clinical research organization
02.2017 - 06.2018
Bachelor of Science (B. Sc) - Biotechnology
M.E.S College of Arts Commerce and science
Master of Science (M. Sc) - Biotechnology
Government Science college