Precision for Medicine
Healthcare
ClinicalDataAssociateII
“Clinical Data Associate II at Precision for Medicine. Skills: Data management support, Clinical trial data management, Database build and testing, Data entry and quality control, Medical coding, SAS programming. Provide data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock. Perform database development and testing”
Industry & Context.
Assist in identifying and troubleshooting operational problems, issues, obstacles, and barriers for studies
May require some travel
What They're Looking For.
Must Have
Bachelors, 2 to 4 years’ experience, Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, Able to handle a variety of clinical research tasks, Excellent organizational and communication skills, Professional use of the English both written and oral
Nice to Have
Experience in a clinical, scientific or healthcare discipline
What You'll Do.
Provide data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock
Perform database development and testing
Perform data entry for paper-CRF studies
Perform quality control of data entry
Develop CRF specifications from the clinical study protocol
Coordinate the review/feedback from all stakeholders
Assist in building clinical databases
Conduct database build UAT and maintain quality controlled database build documentation
Assist in specifying requirements for all edit check types
and maintain data management documentation
Train clinical research personnel on the study specific CRF
and other project related items
Review and query clinical trial data according to the Data Management Plan
Assist in line listing data review
Run patient and study level status and metric reporting
Perform medical coding of medical terms
Assist with coordinating SAE/AE reconciliation
Liaise with third-party vendors
Assist with SAS programming and quality control of SAS programs
Assist in identifying and troubleshooting operational problems
and barriers for studies
Review and provide feedback on protocols
Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs)
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation
How You'll Work.
Team & Collaboration
Support the Lead DM as a back-up and/or team member; Coordinate the review/feedback from all stakeholders; Communicate with study sponsors, vendors and project teams as needed; Input from project team members and other stakeholders
Communication Scope
Excellent communication skills; Professional use of the English both written and oral; Communicate with study sponsors, vendors and project teams as needed; Present software demonstrations/trainings, department/company training sessions, present at project meetings
Process & Methodology
Coordinate review/feedback from all stakeholders, Liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
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