Apr 2024 – Present · 2 yrs 1 mo

• Manage all phases of data management activities from study start up to database close
• Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation, SAE reconciliation.
• Lead/perform user acceptance testing on clinical database setups.
• Provide input on the data management timelines and coordinate the DM operational activities during database set up.
• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
• Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
• Track and review CRFs. Support data entry where required.
• Direct team members in daily activities.
• If required, facilitate cross functional team meetings both internally and externally • Actively review and provide feedback on study productivity.
• Effective time management in order to meet daily metrics or team objectives.
• Shows commitment to and performs consistently high-quality work.

Oct 2021 – Mar 2024 · 2 yrs 5 mos

• Performing data entry into databases (Medidata Rave, DataLabs, iVal, ClinBase™) to ensure accuracy and compliance with SOPs.
• Developing and executing User Acceptance Testing (UAT), collaborating with programmers and supporting the implementation of new product features.
• Acting as a point of contact for local lab data management, resolving queries through effective communication with clinical sites and stakeholders.
• Preparing study-level documents (Protocol Deviation Specification, Data Validation Specification, Data Management Plan) and generating metrics for Global Data Operations, reporting to the Leadership Team.
• Implementing new workflows, resulting in a 50% increase in billability, and overseeing data cleaning activities on projects for efficient and high-quality data management.
• Training and mentoring new Data Support Specialists (DSS), providing working direction, proactive support, and creating a DSS Handbook for future reference.
• Working in compliance with ICH GCP and industry standards, ensuring adherence to PAREXEL SOPs and written procedures in all data management activities.

Oct 2019 – Sep 2021 · 1 yr 11 mos

• Conducting data entry into databases (Medidata Rave, DataLabs, iVal) and working on AZ Archiving on multiple studies.
• Tracking and scanning data into PXL Tools, performing quality checks of study data, and assisting in query management.
• Reviewing study-specific guidelines, creating Data Entry Guidelines and Data Management Plan.
• Participating in trainings, continuing to learn, and implementing new data entry and systems.
• Supporting administrative work for the Data Management Department, including training new DSS as a mentor.
• Creating a DSS Handbook for future reference and providing working direction to DSS proactively.
• Effectively managing time to meet daily metrics and adhering to agreed timelines in all activities.