Gulshan Ara Alam
Clinical Data Manager
Assam,AS
Summary
Seeking challenging assignments where my experience and expertise will be fully utilized towards the continued company growth and my advancement is based upon my skills and contributions. Looking for a long-term relation with a company where I get a chance to showcase my skills and further improve my growth with the company.
Overview
18
18
years of professional experience
Work History
Team Leader Clinical Data Management
Cognizant Technology Solutions India Ltd
- Coordinates and leads the work of data management resources for assigned group and ensure appropriate allocation of work
- Communication of Resource issues to Team Manager
- Perform data management activities on the assigned project in a timely and efficient manner; meet the SLA and KPI of the process
- Test and execute validation procedures
- Prepare study documentation like validation procedure specifications, Level-1 corrections documents, CRF Completion guidelines etc
- For the assigned study
- Provide feedback to the clinical team on protocol and CRF
- Coordination of all the Data Management activities
- Attend Study Team Meetings and Update the team on DM issues and deliverable status when requested
- Interact with Study Manager and other team members on issues of protocol details
- CRF/DB design, Data Quality Specifications
- Interact with the Project Data Manager for data management, standards, or technical issues that is study/program related
- Interact with other stakeholders (e-data loaders, programmer, etc.) as necessary to deliver on the data management requirements
- Take an active role in any initiatives, forums and contributes to projects and trials according to functional area of expertise
- Ensure Audit Readiness for all trial assigned
- Provide inputs to performance assessments of the DMs in the team
- Identify and plan training needs to the assign team members
- Timely issue escalation
- Share best practices across team
- Provide feedback and conduct appraisals for all direct reports
Clinical Data Co-Ordinator
Quintiles India
- End to end responsible for a study, from Startup, conduct, and Lock phase
- SAE Reconciliation
- Clean the data to available for Submission for data analysis by SDTM model
- Direct communication with the Client via Telecon and Mails
- Startup Phase: Design the CRF in OC/RDC/Inform/RAVE database
- Part of the Edit checks
- UAT of the CRFs and the Edit checks
- Mapping of the Front End and Back End data by SDTM model
- Conduct Phase: After Study Go live, Patient Enrolled into a study cleans the data, clean the patient adds to Final clean patient applet
- Clean all the patients in a study lock the patients after Source Data Verification and lock and freeze the study
Study builder (OC Build)
- Worked as a Study Builder for 3 months
- Ensure to complete building of a clinical study from objective setting in OC to create the screen in e-designer
- Create a link between Oracle Clinical and Application Framework and e-designer to reflect the same screen in RDC User Interphase
Associate Data Team Lead
PPD Inc, part of Thermo Fisher Scientific
9 2020 - Current
- Acted as the clinical data team lead for projects supporting the clinical data team lead by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks
- Applies relevant components of the project protocol to daily tasks with guidance
- Delivers study specific training to junior associates for assigned projects
- Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met
- Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
- Monitors for risks to deadlines and escalates appropriately
- Creates and maintains data management project documentation
- Participates in team and client meetings and supports the clinical data team lead with risk management on allocated projects
- Provides input into project forecasting of hours and identification of resource requirements
- Monitors study metrics and runs project-specific status reports for management
- Reviews data management deliverables for allocated projects following documented guidelines
- Produces project-specific status reports for management, PM and/or clients on a regular basis
Clinical Data Validation Associate (CDVA)
Accenture Private Limited
12.2006 - 05.2010
- Ensure the completeness and validity of the clinical trial data that has gone through data entry
- Review and resolve discrepancies identified by the system or through manual checks as per guidelines
- Issue data clarification forms as and when required
- Track, review and close all DCFs responses received
- Fix the validation for post production change through change control form
- Generate and review CRM summary report and track missing CRFs
- Review and address all clinical data review issues
- Review and validate Bio-Analytical data
- Handling the Lab data and Interact with the onshore lab specialist for any kind of lab issue
- Reconcile the vendor data
- Provide expert comments and feedback on quality initiatives like DP skill center
- Interact with the on-shore resources regarding data quality issues
- Take the study call with CDPM on weekly basis
- Responsible for track the missing page, Missing signature, Study status tracker and editing status tracker
- Ensure timelines set by the client in terms of pages produced and clean patient delivery met
- Part of a project 'Green Star' to find out the Aging of Discrepancies
- Mentor DVSs to perform editing till they are certified
- Assist team leaders in resolving complex issues
Education
M.Sc in Biotechnology, 1st Class -
Bangalore University
B.Sc (Zoology) - undefined
Guwahati University
10+2 - undefined
Guwahati University
HSLC - undefined
Government Girls High School, Dhubri
Diploma in computers - undefined
Skills
Experience in working on RAVE, VEEVA VAULT, InForm, OCRDC, Omnicom Trial Master, Encapsia Databases
Extensive Knowledge of Clinical Data Management process, Understanding of ICH-GCP and applicable regulatory guidelines
Understanding of drug development process, clinical trial methodology, and medical terminology
Excellent Communication and interpersonal skills with the ability to operate effectively in a global environment
Strong technical and problem-solving skills
Good organizational, planning and project management skills
Good Team Co-ordination and motivation skills
Ability to demonstrate initiative and pro-activeness
Strong leadership collaborative behavior
Attention to detail and quality focused
Irrespective of my professional qualification, my human qualities like team spirit, interpersonal skills and leadership qualities makes me confident and up to date in today's managerial scenario
Problem-Solving
Mentoring
Languages
English, Hindi, Bengali, Assamese, Kannada
Personal Information
- Date of Birth: 10/10/80
- Gender: Female
Teammanagementprocessmanagement
Over 12 years of experience as Team Lead (DM) and Trial Data Manager, Associate Data Team Lead, Clinical data validation associate, Clinical Data Coordinator. Study therapeutic experience spans across several therapeutic areas of various complexity levels and size. Highly communicative team player who motivates and mentors people at all levels of expertise and manages, directs, and coordinates Data Management activities within the assigned DM group to enable all projects to be conducted with quality, consistency, and timelines.
Awards
- Spot Awards on more than one occasion for valuable contribution to the team (Accenture)
- Numero Uno Award for overall excellence - June 2008 (Accenture)
- Awarded with Celebrating Points for valuable contribution to the team
- Have been one of the top performers of the team for Oncology/Vaccine Therapeutic Area and also in Study Build.
- S1 Awards – Oct 2010 (Quintiles India)
Extracurricular Activities
Member of Hi-Life Team (Accenture) Take part in all the cultural activities in Accenture and participated in Winter Dance Competition among corporate sectors. Conduct the Fun Activities for my team as well as weekly Hi-Life and Monthly Community Events.
Disclaimer
I hereby affirm that the information given above is accurate & true to the best of my knowledge.
Timeline
Clinical Data Validation Associate (CDVA)
Accenture Private Limited
12.2006 - 05.2010
Team Leader Clinical Data Management
Cognizant Technology Solutions India Ltd
Clinical Data Co-Ordinator
Quintiles India
Study builder (OC Build)
Associate Data Team Lead
PPD Inc, part of Thermo Fisher Scientific
9 2020 - Current
M.Sc in Biotechnology, 1st Class -
Bangalore University
B.Sc (Zoology) - undefined
Guwahati University
10+2 - undefined
Guwahati University
HSLC - undefined
Government Girls High School, Dhubri