Clinical Data Analyst

JOB OVERVIEW

The Clinical Data Manager assists and supports the planning, execution and delivery of Clinical Data Management projects on schedule and within budget in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements.

JOB RESPONSIBILITIES

• Develop and implement project timelines.
• Plan and execute multiple data management projects simultaneously.
• Provide input, assistance and/or oversight with preparation of edit check specifications, case report form (CRF) design and specifications.
• Assist and/or oversee the creation of test data for entry screens and edit checks.
• Assist and/or oversee user acceptance testing (UAT) for assigned projects.
• Create and maintain the project specific Data Management Plan (DMP) and other relevant study documentation.
• Assist and/or provide study status tracking and metrics.
• Review of data listings and reconciliation
• Discrepancy and query management
• Ongoing maintenance of electronic trial master file (eTMF)
• Perform study finalization activities.
• Ensure team member performance supports project budget and delivery requirements.
• Participate in and attend study team meetings, as required.
• Participate in department meetings and initiatives.
• Participate in and/or contribute to sponsor and/or regulatory audits and inspections.
• Perform other duties as required by the department.

QUALIFICATIONS

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• 2 to 5 years data management experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
• Additional relevant work experience will be considered in lieu of formal qualifications.
• Broad knowledge of drug development processes
• Understanding of global clinical development budgets and relationship to productivity targets