Bibi M. Email & Phone Number

Dallas, Tx, Us

• Performs oversight function to ensure quality data delivery from all vendors and serves as the point of contact for the external vendors. • Leads and manages internal and external communications regarding data-related deliverables, metrics, and timelines.• Manages custom software configuration and database building with strong understanding of clinical study protocol schedule of assessments.• Responsible for the rapid identification, management, and resolution of discrepancies within the agreed workflow to ensure adherence to study timelines.• Manages and oversee all aspects of data management through study start up, maintenance, and closeout• Oversee the development and maintenance of data management documents such as eCRFs/design specifications, Data Management Plans, Edit Check specifications, CRF Completion guidelines, Data Transfer Specifications

• Participated in the review of Protocol, CRF, and Database Migration Document.• Assisted in the Development of Database as per the study-involved in coding, testing, QC of the database, eCRF design• Involved in the development of various study documents like Edit Check Specification, Data Validation Specification and eCRF completion guidelines• Performed data review, query generation/closure and coding of verbatim terms such as adverse events and concomitant medications.• Provided ad-hoc report development, and support database lock and archiving activities.