Senior Clinical Data Manager (Remote)

About the Role

Our client is seeking a highly experienced and meticulous Senior Clinical Data Manager for a fully remote position. This role is critical for ensuring the quality, integrity, and accuracy of clinical trial data that supports regulatory submissions and decision-making. You will lead data management activities from database design through database lock, working closely with cross-functional teams including biostatisticians, clinical programmers, and clinical operations. This is an excellent opportunity for a seasoned data manager to work independently on complex global clinical trials, contributing significantly to the success of drug development programs from a remote setting.

Key Responsibilities

• Oversee all aspects of clinical data management, including database design, data entry guidelines, data validation, and query resolution.
• Develop and review data management plans (DMPs), edit check specifications, and data validation plans.
• Lead User Acceptance Testing (UAT) for clinical databases and other data management tools.
• Ensure compliance with ICH -GCP guidelines, regulatory requirements, and company SOPs throughout the data lifecycle.
• Manage data cleaning activities and ensure timely database lock for clinical studies.
• Collaborate with clinical operations, biostatistics, and programming teams to ensure data consistency and quality.

Requirements

• Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field.
• Minimum of 6 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, EDC systems (e.g., Medidata Rave, Oracle Clinical), and data standards (e.g., CDISC).
• Proven experience in leading data management activities for complex, global clinical trials.
• Strong understanding of GCP and regulatory requirements related to data integrity.
• Excellent analytical, problem-solving, and project management skills, with the ability to manage multiple projects simultaneously in a remote environment.

Benefits

• A competitive senior-level salary and comprehensive benefits package, including health, dental, and vision insurance.
• The significant advantage of a fully remote working arrangement, offering flexibility and work-life balance.
• Exposure to cutting-edge clinical research and the opportunity to contribute to life-saving therapies.
• Continuous learning opportunities and professional development resources.
• A collaborative and supportive virtual team environment that values expertise and contribution.