CDA III
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
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Job ID 7200
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Career Level Executive
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Experience 2 Years
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Gender MaleFemale
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Category / Function Management
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Qualifications Degree Bachelor
Job Description
Description
Clinical Data Associate III
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neigh
- 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).
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.