What are the responsibilities and job description for the Clinical Data Manager position at Katalyst CRO?
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.
- 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.