Billie Bililign Email & Phone Number

Springfield, Va, Us

Boston, Massachusetts, United States

Serves as primary DM contact in assigned studies for data management tasks from database development, data review and cleaning to database lock and study archive.Oversees the vendors responsible for all Data Management activities and supply study data, inclusive of a Functional Service Provider and CRO Supervises the development of data management plans, data entry guidelines, data validation specifications, metrics/dashboard reports and other documents as required. Ensures the data management activities are executed according to the Data Management PlanSupports database development activities and oversees CRF/database amendment and change control process.Oversees the generation of queries and the resolution of all data related issues prior to database lock. Oversees reconciliations of all third-party data with EDC database and reconciliation of clinical and safety database Oversees the archive of data management related study documents. Maintains the Data Management section of the eTMF of assigned studies.

Blue Bell, Pa

Embedded member of the Sponsor team; primary point of contact for data management activities.Oversee the data management strategy and project plans for collection and integration of clinical data including CRF, LAB, IWR, ePRO.Ensures appropriate use of standards and project-level consistency of database design, data collection and validation.Lead cross-functional, global teams to ensure all aspects of the project plan are executed on time and with quality.Lead and facilitate project team meetings, providing updates on study status to the cross-functional team.Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.

Acts as the Lead Clinical Data Manager for multiple CNS protocols and effectively manage outsourced studies.

Performed data review activities including generation of queries both programmed and manual, updating & resolution of queries, ran metrics reports, etc.

Performed Quality Control responsibilities, including writing data validation checks, reviewing data discrepancies, performing database queries, and contacting trial sites for resolution.

Durham, Nc

•Utilized Clintrial database system to validate clinical data collection and quality control review of case report forms (CRFs) received from trial sites to ensure compliance with multiple protocols, FDA regulations and GCP guidelines for Phase II-III clinical trials.•Reviewed CRFs for missing or inconsistent data.•Generated data clarification forms (DCF) through consistency checks, SAS programming checks and CRF discrepancies.•Updated Clinical Database from DCFs.•Performed quantitative CRF audits by comparing data listings to CRFs. •Conducted SAE and Lab data reconciliation.

•Served in a support-level capacity on a Clinical Data Management (CDM) team to provide efficient, quality Data Management products that met clients’ needs.•Assisted in ensuring clinical database integrity and performance.•Provided support in QA/QC of clinical data. •Reviewed Case Report Forms (CRF) for completion. •Performed first and second data entry and verification.•Documented, resolved, and integrated data queries.