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Title
Text copied to clipboard!Clinical Data Manager
Description
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We are looking for a Clinical Data Manager to join our dynamic team in the healthcare industry. The ideal candidate will be responsible for ensuring the accuracy and integrity of clinical trial data. This role involves coordinating with clinical research staff, managing data systems, and implementing data standards to ensure compliance with regulatory requirements. The Clinical Data Manager will play a crucial role in the success of clinical trials by overseeing the collection, processing, and storage of data. This position requires a detail-oriented professional with strong analytical skills and a deep understanding of clinical data management processes. The successful candidate will work closely with cross-functional teams to support the design, execution, and reporting of clinical studies. This role is pivotal in ensuring that data collected during clinical trials is accurate, complete, and verifiable, thereby contributing to the advancement of medical research and the development of new treatments. If you are passionate about improving patient outcomes and have a strong background in data management, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Develop and implement data management plans for clinical trials.
- Ensure data integrity and compliance with regulatory standards.
- Coordinate with clinical research staff to manage data collection and entry.
- Monitor data quality and perform data cleaning activities.
- Manage electronic data capture (EDC) systems and databases.
- Develop and maintain data management documentation and SOPs.
- Train clinical research staff on data management practices.
- Perform regular data audits to ensure accuracy and completeness.
- Collaborate with biostatisticians and other team members to prepare data for analysis.
- Resolve data discrepancies and queries in a timely manner.
- Ensure secure and confidential handling of clinical data.
- Participate in the selection and management of external data management vendors.
- Support the preparation of regulatory submissions and reports.
- Stay updated on new data management technologies and best practices.
- Contribute to the development of data standards and data sharing policies.
Requirements
Text copied to clipboard!- Bachelor's degree in a relevant field (e.g., Life Sciences, Biostatistics, or Computer Science).
- Minimum of 3 years of experience in clinical data management.
- Strong understanding of clinical trial processes and regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical data management systems (CDMS).
- Proficiency in data management software and databases.
- Excellent analytical and problem-solving skills.
- Strong organizational skills and attention to detail.
- Ability to work effectively in a team and communicate with diverse groups.
- Knowledge of Good Clinical Practice (GCP) and data privacy regulations.
- Experience in managing external vendors and contractors.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with electronic data capture systems?
- How do you ensure data integrity and accuracy in a clinical trial?
- What strategies do you use to manage large datasets and ensure timely data cleaning?
- Can you give an example of a challenging data management issue you faced and how you resolved it?
- How do you stay updated with the latest data management technologies and regulations?
- Describe your experience with regulatory submissions and the role of data management in that process.
- How do you approach training and mentoring staff on data management practices?
- What is your experience with developing and implementing data management plans?
- How do you handle data discrepancies and queries from clinical research sites?
- What do you consider the most important aspect of data security and confidentiality in clinical trials?