Ankita Thakkar

• Lead and coordinate complex clinical trials from a data management perspective, ensuring high-quality data deliverables across all study phases.
• Provide expert data management input during protocol development and study start-up activities, including kick-off meetings.
• Propose and implement database design strategies tailored to study-specific requirements and challenges.
• Collaborate with Clinical Project Managers to define and maintain timelines for data management deliverables.
• Design, build, validate, and maintain clinical trial databases in compliance with study protocols, GCP, and internal SOPs.
• Develop and review Case Report Forms (CRFs) and ensure timely implementation of cross-functional feedback.
• Configure, test, and manage Electronic Data Capture (EDC) systems; serve as primary database manager for assigned studies.
• Create and manage database specifications; liaise with EDC vendors to ensure accurate and timely deliverables.
• Prepare and/or review key study documentation including Data Management Plans (DMPs), CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications.
• Perform data cleaning activities including review, query generation, and resolution to ensure data accuracy and consistency.
• Code medical terminology such as adverse events (AEs) and concomitant medications in collaboration with clinical/medical teams.
• Reconcile external data (e.g., laboratory results, ECGs, SAE reports) with the clinical database to maintain data integrity.
  Participate in regular study team meetings and present data management status updates and performance metrics.
• Contribute to process improvement initiatives, SOP development, and implementation of data management best practices.
• Provide training to internal teams and external stakeholders (e.g., investigators, site staff) on data management processes and systems.
• Mentor and support junior data management staff, offering guidance and knowledge sharing.
  Offer strategic insights and industry best practices to cross-functional teams to enhance data management efficiency.

● Proficient in data management architectures, policies, and
practices.
● Managed end-to-end data activities from CRF design to database lock.
● Reviewed and ensured adherence to CRF completion
guidelines and monitoring plans.
● Oversaw study timelines, budgets, metrics, and data review
plans, ensuring data integrity.
● Produced, validated, and compiled Case Report forms across
multiple protocols.
● Identified and resolved discrepancies, conducted site queries,
and maintained accuracy.
● Collaborated with external project team members to streamline
data collection and clean-up.
● Supported research staff and aided in progress report
development.
● Conducted data management training & Contributed to team meetings, Local and Lead Node discussions, and data management conference calls.
● Designed and validated clinical databases, implementing logic
checks.
● Generated data queries to address errors and omissions during
data entry.
● Developed project-specific data management plans covering coding, reporting, transfer, database locks, and workflow processes.
● Designed data processing forms and managed clinical data
reception, entry, verification, and filing.
● Created technical specifications for data management
programming and liaised with IT staff.
● Prepared data analysis listings and various reports on activity,
performance, and progress.
Environment: Oracle Apex Custom Applications.

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.
• Assessed the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely and provides regular site status information to team members, trial management, and updates trial management tools.
• Completes monitoring activity documents as required by Veeda SOPs or other contractual obligations.
  Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Escalates site and trial related issues per Veeda SOPs, until identified issues are resolved or closed.
• Performs essential document site file reconciliation and source document verification and query resolution.
• Assesses IP accountability, dispensation, and compliance at the investigative sites.
• Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.
• Communicates with investigative sites and updates applicable tracking systems.
• Ensures all required training is completed and documented. Serves as observation visit leader to Facilitates audit s and audit resolution.
• Excellent knowledge of ICH/GCP to manage investigative sites to facilitate trial deliverables to escalate issues appropriately.
  Conducts monitoring to confirm subject safety and data integrity and describes and demonstrates the principals of IP accountability.
• Identifies scientific misconduct at the site level and demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems (CTMS), IVRS/IWRS and Electronic Data Capture (EDC) platform.
  Conducts monitoring evaluation visits to Assists team lead in the development of trial tools or documents.