CDA III

Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary


Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s)


Creates and enters test data for User Acceptance Testing (UAT)
Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices


Receives and enters lab normal ranges


Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets


Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database

Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects

Resolves answered queries and re-queries where appropriate


For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly

Submits copies of the DCFs to sponsors as necessary


For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs

Serves as QC Coordinator for paper studies


For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects


For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems


Creates electronic storage media per SOPs for EDC studies


Participates in internal meetings and internal/external audits as required


Files documentation in the Data Management Study File (DMSF)


Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College)


Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs


Coordinates the work of CDAs assigned to the project


Provides training on data management activities and systems


Provides project-specific training to other Clinical Data Associates (CDAs)


Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database

Uses the specified process to document and query any such discrepancies found with the appropriate party


Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload

Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts

Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries


Runs data cleaning and/or status reports


Performs Serious Adverse Event (SAE) reconciliations


Performs peer review to other CDAs and provides feedback


Understand how data management interacts with other Data Operations teams (Safety, Medical Writing, Biostatistics, Clinical Programming, and Coding)


Performs QC of Data Dictionary for code lists
Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements)


Performs post-migration testing on screens, edit checks, matrices and role changes as required


Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution


Reviews database design specifications (including configuration, data structures, annotated CRFs)


Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design


Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance


Project Data Manager (PDM) back up for specific activities (including attend sponsor s meetings to provide updates)


Creation of Discoverer, BOXI, J-Review Reports


Updates the Data Management Plan under the guidance of the PDM


Supports PDM on updating documents (DMP, data import/export agreements) according to Trusted Process (TP)


Creates and updates the CRF/eCRF Completion Guidelines


May fill-in the Data Transfer Request Form required for delivering the data to sponsor or vendor


Understands the coding process
Understands the purpose of interim, dry run, data cut

Qualifications

What we re looking for

BA/BS degree in the biological sciences or related disciplines in the natural science/health care field

4 to 6 years of experience in Clinical Data management activities

Central Lab (Non CRF Data unprocessed data will be a value add Strong Conduct and Closeout Phase, experience in - (Query Management, experience with Spotfire, Vendor & SAE Reconciliation, Lab query management added advantage)

Good to have Startup experience - UAT, Migrations, DM Documentation

Closeout - (DB Lock, Freezing & Locking)

Hands on Exposure with Veeva/RAVE/ INFORM or any EDC platform

Exposure of Oncology trials would be preferred

Experience with DM practices and relational database management software systems preferred


Oracle Clinical, Rave, or Inform systems preferred

Knowledge of clinical data, and ICH/Good Clinical Practices

Knowledge of medical terminology preferred


Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications

Excellent speed and accuracy of keyboard skills


Work experience in clinical research, drug development, data management, or other healthcare environment preferred


Familiarity with medical terminology


Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade


Good organizational, planning, and time management skills preferred

Ability to multitask under tight deadlines while providing attention to detail

Ability to be flexible and adapt to change

Ability to work independently as well as part of a multi-disciplinary team


Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management

Minimal travel may be required (up to 25%)