Clinical Data Manager

Summary

Clinical Ink is a global life science company that combines data, technology, and patient science to advance clinical discovery and clinical trials. The Clinical Data Manager will design, implement, and manage data management activities for assigned clinical trials, including data management plans, database validation, surveillance, discrepancy investigation, and ETL activities. The role also involves collaborating with clinical research teams, mentoring team members, and leading client discussions.

Responsibilities

• Design, implement, and manage all data management activities for assigned clinical trials
• Develop and implement data management plans
• Create and maintain validation plans for clinical databases
• Develop and implement data surveillance plans for clinical trials
• Identify and investigate data discrepancies and signals
• Report data anomalies
• Lead data mapping and ETL related activities as part of the management of a clinical database data pipeline
• Work with other members of the clinical research teams to ensure that data is collected and managed in a timely and accurate manner
• Stay up-to-date on clinical data management standards and regulations
• Train and mentor other members of the clinical data management team
• Lead client discussions regarding data management activities

Skills

• Bachelor's degree in a field such as statistics, computer science, or health science or equivalent experience
• 3+ years of experience in clinical data management
• Experience with clinical databases and data management software
• Excellent problem-solving and analytical skills
• Knowledge of applicable regulations and policies; working knowledge of the clinical development process, clinical practice, and medical terminology
• Ability to work independently and act with appropriate accountability with minimal guidance by a manager or as part of a team
• Ability to coordinate the work of others and influence decision-making
• Exceptional communication skills (oral and written), with the ability to communicate with both technical and business topics
• Strong project management and organizational skills
• Knowledge of database structures and available tools to manage, extract, and report data

Qualifications

Must Haves

• Bachelor's degree in a field such as statistics, computer science, or health science or equivalent experience
• 3+ years of experience in clinical data management
• Experience with clinical databases and data management software
• Excellent problem-solving and analytical skills
• Knowledge of applicable regulations and policies; working knowledge of the clinical development process, clinical practice, and medical terminology
• Ability to work independently and act with appropriate accountability with minimal guidance by a manager or as part of a team
• Ability to coordinate the work of others and influence decision-making
• Exceptional communication skills (oral and written), with the ability to communicate with both technical and business topics
• Strong project management and organizational skills

Nice to Haves

• Knowledge of database structures and available tools to manage, extract, and report data

Benefits

• Remote work across the United States