Clinical Data Manager

i-Lumen Scientific is focused on improving day to day life for patients affected with Age-related Macular Degeneration (AMD).

The Clinical Data Manager, based in Minnesota, can be a remote position, and coordinate with both our Australian and U.S. Clinical Operations teams. This role will own the CDM from database development through study close-out and is critical to ensure ensure data quality and compliance with regulatory authorities.

Applicants must be currently living in and legally able to work in Australia.

Responsibilities

• Works under minimal guidance and participates in the planning, implementation and oversight of clinical research projects and protocols, contributing technical and clinical data management expertise.
• Support Data Management to execute clinical trials smoothly in terms of all operational aspects of study start-up, maintenance, and close-out.
• Design and implement efficient processes and procedures for data collection and management.
• Participate in development of case report forms (CRFs) and data collection methods for the study database.
• Manage and ensure the integrity of clinical databases, including the creation and management of specifications, user testing and verification of study databases.
• Perform thorough data cleaning and validation to ensure data accuracy.
• Responsible for coding and categorizing data appropriately.
• Address data queries and discrepancies, and make necessary corrections.
• Develop and maintain data management plans and documentation.
• Collaborate with clinical teams and statisticians to resolve any data issues.
• Ensure compliance with regulatory standards and protocols.
• Participate in the preparation of reports and manuscripts.

Qualifications

• 5+ years experience in Clinical Data Management
• BS degree, in Life Sciences, Biostatistics or relevant field
• Knowledge of Good Clinical Practice, ICH and Declaration of Helsinki.
• Excellent communication, interpersonal and organizational skills
• Ability to collaborate in a team environment as well as work independently
• Self-starter with the ability to manage multiple projects in a dynamic environment