Clinical Data Manager

Responsibilities

• Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
• Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
• Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
• Develop and oversee maintenance all data management documentation for all clinical studies.
• Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
• Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
• Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
• Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
• Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
• Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
• Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
• Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution.
• Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency.
• Develop, implement, and continuously improve clinical data management processes and systems.
• Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.

Requirements

• Bachelor's or master's degree in life sciences, health informatics, computer science, or related field.
• Advanced degree preferred.
• Strong understanding of data structure and data systems.
• Minimum of 5+ years of experience in clinical data management.
• Proven experience managing data across multiple phases of clinical trials.
• Proficiency with EDC systems (e.g., Medidata Rave, Medrio).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding.
• Familiarity with data reporting tools is a plus.
• Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards.
• Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, problem-solving, and decision-making skills.
• Ability to work collaboratively with cross-functional teams and manage relationships with external vendors.
• Certified Clinical Data Manager (CCDM) or similar certification is preferred.