Clinical Data Associate III – Min 2 years of previous data management exp

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Maintains awareness of relevant contract elements and scope of work for assigned projects, providing status updates to the Project Manager and/or Biometrics Project Manager as needed.

• Reviews and complies with the requirements outlined in study-specific Clinical Data Management Plans for assigned projects.

• Creates and inputs test data for User Acceptance Testing (UAT).

• Conducts User Acceptance Testing (UAT) for data entry screens, edits, data review listings, various roles utilized in the study, and Targeted Source Data Verification (SDV) configuration and matrices.

• Receives and records lab normal ranges.

• Completes and submits access forms and/or spreadsheets specific to the Clinical Database Management System (CDMS).

• Reviews discrepancy (edit check) outputs and validation listings based on data entered into the clinical database, applying queries or self-evident corrections as permitted by the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects.

• Resolves queries and requeries as appropriate.

• For paper studies, receives and reviews Data Clarification Forms (DCFs) answered by sites, editing the CRF database accordingly when necessary.

• Submits copies of DCFs to sponsors as required.

• For paper studies, performs internal quality control checks by comparing listing outputs from the database against CRFs and DCFs, acting as the QC Coordinator.

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

• For EDC studies, conducts DM quality reviews and/or additional internal QC checks as necessary based on the applicable electronic data capture (EDC) systems.

• Creates electronic storage media following 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 training (CDA Knowledge College).

• Performs SAS mapping quality control, noting discrepancies in SAS mapping test logs.

• Coordinates the activities of Clinical Data Associates (CDAs) assigned to the project.

• Provides training on data management activities and systems.

• Delivers project-specific training to other Clinical Data Associates (CDAs).

• Ensures consistency of data from external databases/datasets, such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT), with the clinical database.

• Uses the specified process to document and query any discrepancies found with the appropriate parties.

• Completes tasks within established timeframes by effectively prioritizing multiple tasks across projects and adjusts to changes in timelines or priorities by reorganizing daily workloads.

• Proactively communicates accurate estimates on task completion times, availability for new assignments, and any resource conflicts to the project team and management.

• Minimizes rework by following study instructions, seeking clarification of assignments before starting tasks, and anticipating the impact of changes on data when issuing and resolving queries.

• Runs data cleaning and/or status reports.

• Conducts Serious Adverse Event (SAE) reconciliations.

• Performs peer reviews for other CDAs and provides constructive feedback.

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

• Conducts quality control of the Data Dictionary for code lists.

• Creates ad-hoc data cleaning reports to determine if a validated listing is needed, including the creation of specifications for the validated listing (updating DVS with the listing requirements).

• Conducts 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, and ensures that minutes are promptly and accurately shared with the internal team for review and necessary edits to maintain updated records for sponsor distribution.

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

• Designs and/or reviews CRF/eCRF, including eCRF visit structure, in coordination with team members responsible for the associated database design.

• Contributes to the Data Validation Specification (DVS), including creating edit checks for assigned forms and any post-production updates to the DVS and listings under guidance.

• Acts as Project Data Manager (PDM) backup for specific activities, including attending sponsor meetings to provide updates.

• May involve report design.

• Updates the Data Management Plan under the guidance of the PDM.

• Assists the PDM in updating documents (DMP, data import/export agreements) in accordance with the Trusted Process (TP).

⛳️ Requirements

• Minimum of 2 years of prior experience in data management.

🏝️ Benefits

• We are dedicated to developing our people through career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.