Role Description
As a Clinical Data Associate, you will perform activities for assigned studies in support of DM study lead in compliance with company processes, GCP and regulations. Responsibilities may include:
• Editing and updating DM documents
• Conducting UAT testing
• Performing data review
• Discrepancy management
• Data reconciliation
• Data listing generation and distribution
• Tracking issues
• Performing database QC
• Filing DM documents in the trial master file
Specific responsibilities include:
• Facilitate updating DM Documents (Data Management Plan, Data Validation Plan, Data Review Plan, CRF Completion Guidelines) per Lead DM expectations
• Verify external vendor test data per specifications document
• Run and review outputs and database study metrics
• Participate in data reviews
• Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up
• Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation
• Ensure DM procedures and processes are adhered to in a consistent manner
• Provide high-quality services through efficient and compliant processes
Qualifications
• Minimally 2 years of clinical data management experience in a biotech, pharmaceutical, or CRO environment is preferred
• Associate’s degree or higher is required
• Hands-on experience with Electronic Data Capture systems (Medidata Rave desired)
• Excellent communication skills (verbal and written)
• Experienced working in a cross-functional team environment
• Strong organizational skills
Requirements
• The hourly range for roles of this nature are $35.00 to $55.00/hr. Rates are heavily dependent on skills, experience, location, and industry.
Company Description
• cyberThink is an Equal Opportunity Employer.