Clinical Data Manager

About the Role

Our client is seeking a highly organized and experienced Clinical Data Manager to join their global clinical operations team, operating on a remote-first basis. This role is paramount in ensuring the accuracy, integrity, and reliability of clinical trial data, which is essential for evaluating the safety and efficacy of new pharmaceutical products. You will be responsible for the end-to-end management of clinical trial databases, from initial design and setup to database lock. This position requires a keen eye for detail, a strong understanding of clinical trial processes, and the ability to collaborate effectively with diverse, geographically dispersed teams.

Key Responsibilities

• Oversee the design, build, and maintenance of clinical trial databases using EDC systems.
• Develop data management plans (DMPs) and data validation specifications.
• Define data entry guidelines, edit checks, and data review procedures.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Perform User Acceptance Testing (UAT) for database builds and system enhancements.
• Ensure compliance with data privacy regulations (e.g., GDPR) and industry standards (e.g., CDISC).
• Facilitate database lock according to study timelines and quality standards.

Requirements

• Bachelor's degree in a health science, computer science, or related field.
• 3-5 years of experience in clinical data management within the pharmaceutical or CRO industry.
• Proficiency with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC).
• Strong understanding of clinical trial conduct and regulatory requirements (GCP, ICH).
• Excellent knowledge of database design, data validation, and data standards (e.g., CDISC SDTM).
• Exceptional problem-solving skills and ability to manage multiple projects concurrently in a remote setting.

Benefits

• Competitive salary and performance-related bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Flexible remote working arrangements.
• Generous annual leave and company holidays.
• Retirement savings plan.
• Opportunities for professional development and training in data management technologies.