Senior Clinical Data Coordinator - Remote

Overview

The Senior Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed, and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.

In Short

• Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
• Support Lead Data Manager in the areas of Data Review, Data Reconciliation, and Discrepancy Management.
• Report potential protocol deviations and maintain study metrics.
• Generate Ad-Hoc Study Reports and perform User Acceptance Testing.
• Ensure data management documentation is complete and upload documents in the trial master file (TMF).
• Create data management plans and assist with statistical data issues.
• Provide support to other Clinical Data Coordinators and mentor junior staff.
• Participate in internal initiatives to improve data cleaning activities.
• Act as a back-up for the Lead Data Manager.
• Assist in writing test cases and resource allocation for UAT testing.

Requirements

• B.Sc. or related field.
• 1 to 3 years of clinical data management experience in the biotechnology, pharmaceutical or CRO industry.
• Skilled in the use of computer technology and ability to learn new applications.
• Highly organized and detail-oriented with effective project planning and time management skills.
• Strong verbal and written communication skills in English; French is an asset.
• Ability to work in a fast-paced environment with demonstrated agility to prioritize multiple demands.
• Good interpersonal, communication, problem-solving, and organizational skills.
• General knowledge of CDISC standards is an asset.
• Understanding of the drug development process and applicable regulations.

Benefits

• Permanent full-time position.
• Flexible schedule.
• Vacation.
• Home-based position.
• Ongoing learning and development.