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Title
Text copied to clipboard!Clinical Data Manager
Description
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We are looking for a highly skilled and detail-oriented Clinical Data Manager to join our team. The ideal candidate will be responsible for managing and overseeing the collection, storage, and analysis of clinical data for research and clinical trials. This role requires a deep understanding of clinical data management processes, regulatory requirements, and data analysis techniques. The Clinical Data Manager will work closely with clinical research teams, data analysts, and regulatory bodies to ensure the accuracy, integrity, and compliance of clinical data. Key responsibilities include developing data management plans, designing and implementing data collection systems, performing data validation and quality checks, and preparing data for statistical analysis. The successful candidate will have strong organizational skills, the ability to manage multiple projects simultaneously, and excellent communication skills to effectively collaborate with various stakeholders. A background in life sciences, healthcare, or a related field is essential, along with experience in clinical data management software and tools. This is a critical role that contributes to the success of clinical trials and research studies, ultimately impacting patient care and medical advancements.
Responsibilities
Text copied to clipboard!- Develop and implement data management plans for clinical trials.
- Design and maintain databases for clinical data collection.
- Ensure data accuracy, integrity, and compliance with regulatory standards.
- Perform data validation and quality checks.
- Collaborate with clinical research teams to define data requirements.
- Prepare data for statistical analysis and reporting.
- Manage data entry and data cleaning processes.
- Generate and review data listings, summaries, and reports.
- Coordinate with external vendors for data management services.
- Monitor data collection processes to ensure consistency and accuracy.
- Provide training and support to clinical staff on data management procedures.
- Develop and maintain standard operating procedures (SOPs) for data management.
- Ensure timely and accurate data submission to regulatory authorities.
- Participate in audits and inspections related to data management.
- Stay updated on industry trends and regulatory changes in clinical data management.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, healthcare, or a related field.
- Minimum of 3-5 years of experience in clinical data management.
- Proficiency in clinical data management software (e.g., EDC, CDMS).
- Strong understanding of regulatory requirements (e.g., FDA, ICH-GCP).
- Excellent organizational and project management skills.
- Attention to detail and high level of accuracy.
- Ability to manage multiple projects simultaneously.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Experience with data validation and quality control processes.
- Knowledge of statistical analysis and reporting.
- Ability to work independently and as part of a team.
- Familiarity with clinical trial processes and protocols.
- Experience with database design and maintenance.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Potential interview questions
Text copied to clipboard!- Can you describe your experience with clinical data management software?
- How do you ensure data accuracy and integrity in clinical trials?
- What steps do you take to comply with regulatory requirements?
- Can you provide an example of a challenging data management project you handled?
- How do you manage multiple projects with tight deadlines?
- What is your approach to data validation and quality control?
- How do you collaborate with clinical research teams and other stakeholders?
- Can you describe your experience with database design and maintenance?
- How do you stay updated on industry trends and regulatory changes?
- What strategies do you use to train and support clinical staff on data management procedures?