This position is responsible for leading otherClinical Data Associates (CDA) in all data management activities, providingsupport and may function as a backup for the Project Data Manager (PDM) on astudy as required for global clinical trials.
Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and / or Biometrics Project Manager (BPM) as necessary.
Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required.
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 DVS 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.
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.
Participates / Leads in internal meetings.
Attends in-process review meetings.
Participates in 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.
Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed.
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.
Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations.
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).
Perform 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.
Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports.
PDM’s back up for specific activities (including attend sponsor’s meetings to provide updates).
Creation of Discoverer, BOXI, J-Review Reports
Creates, updates and reviews study-specific documents such as CRF / eCRF DMP, data import / export agreements, CRF / eCRF Completion Guidelines.
Fills-in the Data Transfer Request Form required for delivering the data to sponsor or vendor.
Reviews queries and self-evident corrections proposed by less experienced DM staff.
Understands the coding process
Understands the purpose of interim, dry run, data cut
Trains and mentors DM staff providing timely feedback to trainee and management as appropriate.
Trains project team in project specific requirements.
Provides EDC training to internal and external team members via Teleconference.
Serves as a platform or process-specific Subject Matter Expert (SME).
Performs QC of DMSF after QuickStart® Camp (QSC) and ongoing during the study conduct.
May be required to participate in client, internal or agency audits and inspections.
May represent the department at businessdevelopment related meetings.
Must have minimum 5 years of relevant experience in CDM
Must have working experience of 1-2 years on Inform EDC Tool
Must have involved in end-end Data Management activities
Must have expertise on Study Start-up activities
Must have working experience on Local Lab Data Reconciliation