Uses technical, industrial, and interpersonal skills to interpret clinical protocols and customer requirements to create clinical data management system (CDMS) designs and non-CDMS component specifications (including electronic Case Report Forms (eCRFs), dynamic eCRF functionality and eCRF edit checks) to meet the needs of the customer and the clinical trial.

Lead the development of specifications, implementation, and testing for the eCRF.Lead the development of specifications, implementations, and testing for the edit checks and data review and oversight listings (DVS).Lead development of specifications for custom reporting on the study.Key point of contact for the sponsor and the study team on eCRF design, edit checks, and other implemented components.

Lead Data Management point of contact for day to day activity on study, overseeing and coordinating tasks delegated to the study team members both locally and in other offices.

• Performs complex Case Report Form (CRF)/electronic Case Report Form (eCRF) data review including query creation, resolution and listing review independently and efficiently.• Performs essential functions which support database development including CRF/eCRF design, data dictionary quality control (QC) review, user acceptance testing (UAT), SAS listing specification and SAS mapping QC.• Reviews Serious Adverse Event (SAE) and performs external data reconciliations.• Provides… Show more • Performs complex Case Report Form (CRF)/electronic Case Report Form (eCRF) data review including query creation, resolution and listing review independently and efficiently.• Performs essential functions which support database development including CRF/eCRF design, data dictionary quality control (QC) review, user acceptance testing (UAT), SAS listing specification and SAS mapping QC.• Reviews Serious Adverse Event (SAE) and performs external data reconciliations.• Provides support to the Project Data Manager (PDM) on a study as required. Tasks include updating the Data Management Plan (DMP), creating and updating the SAE Reconciliation Plan and eCRF Completion Guidelines and providing input into the Data Validation Specification (DVS).• Provides training and work direction to Clinical Data Associates (CDAs) as required. Show less

• Reviews CRF/eCRF data for quality and consistency in accordance to set protocols • Performs Quality Control (QC) of standard procedures• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings• Performs data reconciliation from external databases/datasets• Coordinates the work of Clinical Data Associates assigned to the project(s)• Provides training and guidance to other Clinical Data Associates in project specific and general tasks… Show more • Reviews CRF/eCRF data for quality and consistency in accordance to set protocols • Performs Quality Control (QC) of standard procedures• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings• Performs data reconciliation from external databases/datasets• Coordinates the work of Clinical Data Associates assigned to the project(s)• Provides training and guidance to other Clinical Data Associates in project specific and general tasks and duties Show less

•Recruited and enrolled study participants•Arranged and performed interviews with study participants•Reviewed medical charts of potential study participants utilizing the appropriate databases or referrals•Performed filling and data entry duties•Secured and shipped clinical samples in accordance to set protocols