Clinical Data Associate III – (Data Acquisition Specialist)
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
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Job ID 8114
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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 neighbors.
Job responsibilities
Specific Responsibilities
ï‚· Ensure eCRF informed consent information is reconciled prior to shipment for analysis, where
appropriate.
ï‚· Communicate and address discrepancies and issues with sample collection information to the
monitor, site and sponsor in a timely manner and ensure appropriate action is taken to resolve the
issue or discrepancy.
ï‚· Ensure sample data information leading to sample shipments are communicated to sponsor
according to the agreed shipping schedule for the study
ï‚· Provide detailed update regarding Sample Data Cleaning on assigned studies to various functions.
ï‚· Ability to review Edit checks document, Data Transfer Agreement.
ï‚· Ability to consult Data Acquisition Specialist for Sample Metadata requirements of Vendors and CRO.
ï‚· Ability to perform the User Acceptance Testing for Sample checks output.
ï‚· Ability develop Sample edit check specifications.
ï‚· Ability to understand and review external data like PK, PD, Biomarker, Tissue sample etc.
ï‚· Ability to review data in real time and raise queries.
Specific Responsibilities
ï‚· Ensure eCRF informed consent information is reconciled prior to shipment for analysis, where
appropriate.
ï‚· Communicate and address discrepancies and issues with sample collection information to the
monitor, site and sponsor in a timely manner and ensure appropriate action is taken to resolve the
issue or discrepancy.
ï‚· Ensure sample data information leading to sample shipments are communicated to sponsor
according to the agreed shipping schedule for the study
ï‚· Provide detailed update regarding Sample Data Cleaning on assigned studies to various functions.
ï‚· Ability to review Edit checks document, Data Transfer Agreement.
ï‚· Ability to consult Data Acquisition Specialist for Sample Metadata requirements of Vendors and CRO.
ï‚· Ability to perform the User Acceptance Testing for Sample checks output.
ï‚· Ability develop Sample edit check specifications.
ï‚· Ability to understand and review external data like PK, PD, Biomarker, Tissue sample etc.
ï‚· Ability to review data in real time and raise queries.
General Responsibilities
- 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).