Clinical Data Manager

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.

EXPERIENCE - 1 to 8 Yrs

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 AND EDUCATION REQUIREMENTS

• 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+ 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