Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Clinical Data Manager

  • Sep 2020 - Present

  • Responsible for financial management of assigned projects. • Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management. • Coordinate the work of CDAs, clinical database programmers and medical coders assigned to the project. • Collaborate with safety team to perform reconciliation of serious adverse events and other trial-specific events • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings. • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations. • Develop and maintain project plans, specifications, and documentation in line with SOP requirements. • Create and maintained all project start-up documents; including eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications. • Create and maintained project timelines. • Provides project specific training to internal and external audiences as required. Show less



Veristat

• United States
• Research Services
• 300 - 400 Employee

• Clinical Data Manager | Clinical Data Manager II

  • Jul 2018 - Aug 2020

  • Worked with project manager and clinical team for query resolution.• Created data management plan according to sponsor SOP and guidelines.• Performed data cleaning and query handling• Supported preparation of data reports• Developed and designed CRFs and review of sponsor generated CRFs.• Performed data validation and edit checks.• Maintained key clinical study data for reporting to data operations manager and the clinical teams.• Provided status updates on data entry and data quality metrics.• Manage vendor evaluation, qualification, and selection activities.• Responsible for overseeing up-to-date and quality data entry into EDC by clinical sites.• Adhered to data security and confidentiality requirements when handling confidential data.• Ensured adherence to GCP and GDMP and all applicable local and international regulations Coordinate the work of the assigned Data Management/Data Operations team. Show less

• Clinical Data Associate | Clinical Data Manager

  • Mar 2016 - Jul 2018

  • Issued queries and reviewed query responses with the highest level of quality based in accordance with the data review plan/guidance document, including manual review (AE/CM comparison, Inclusion/Exclusion review, etc.), and reconciliation (LAB, SAE, ECG, and other vendors)• Created User Acceptance Test scripts from edit check specifications and create dummy data to test edit checks and to test database screen functionality.• Drafted the CRF design, edit check specification and DM listings• Facilitated clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc)• Managed all database build and modifications (expectations for timelines, UAT, production release)• Supported CDM process and application improvements; participate in working groups to develop and implement new processes and applications. Show less