[Hiring] Clinical Data Associate III / Sr CDA @Syneos Health

Role Description

• 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.
• Resolves answered queries and requeries 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).
• Possibly design of 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).

Qualifications

• Min 2 years of previous data management experience.
• Experience in clinical data management processes.

Requirements

• Proficiency in Data Management systems and processes.
• Ability to prioritize multiple tasks and adapt to changes.
• Strong communication skills.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.