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Title
Text copied to clipboard!Clinical Data Specialist
Description
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We are looking for a dedicated and detail-oriented Clinical Data Specialist to join our team. The ideal candidate will be responsible for managing, analyzing, and ensuring the integrity of clinical data. This role is crucial in supporting clinical research and ensuring that data is accurate, complete, and compliant with regulatory standards. The Clinical Data Specialist will work closely with clinical research teams, data managers, and other stakeholders to develop and implement data management plans, perform data validation, and generate reports. The successful candidate will have a strong background in data management, excellent analytical skills, and a thorough understanding of clinical research processes. They will also be proficient in using data management software and tools, and have a keen eye for detail. This position requires excellent communication skills, as the Clinical Data Specialist will need to collaborate with various departments and present findings to senior management. The role also involves staying up-to-date with industry trends and regulatory requirements to ensure best practices in data management. If you are passionate about clinical research and have a knack for data, we would love to hear from you.
Responsibilities
Text copied to clipboard!- Manage and maintain clinical data systems.
- Develop and implement data management plans.
- Perform data validation and quality checks.
- Generate and analyze data reports.
- Ensure data integrity and compliance with regulatory standards.
- Collaborate with clinical research teams and data managers.
- Provide training and support to staff on data management processes.
- Monitor data collection processes and identify areas for improvement.
- Prepare data for submission to regulatory authorities.
- Stay up-to-date with industry trends and regulatory requirements.
- Assist in the design and development of clinical databases.
- Conduct data audits and resolve discrepancies.
- Develop and maintain standard operating procedures for data management.
- Participate in project meetings and provide data management updates.
- Ensure timely and accurate data entry and documentation.
- Support the development of data management tools and software.
- Coordinate with IT teams to ensure data security and backup.
- Review and approve data management documentation.
- Assist in the preparation of clinical study reports.
- Provide input on data management best practices.
Requirements
Text copied to clipboard!- Bachelor's degree in a related field (e.g., Life Sciences, Data Management).
- Minimum of 3 years of experience in clinical data management.
- Proficiency in data management software and tools (e.g., SAS, SQL, EDC systems).
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Knowledge of clinical research processes and regulatory requirements.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Experience with data validation and quality control.
- Familiarity with data privacy and security regulations.
- Ability to manage multiple projects and meet deadlines.
- Strong organizational skills.
- Experience with database design and development.
- Ability to train and support staff on data management processes.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Experience with clinical trial management systems (CTMS).
- Knowledge of Good Clinical Practice (GCP) guidelines.
- Ability to prepare and present data reports.
- Experience with data auditing and discrepancy resolution.
- Strong technical writing skills.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with clinical data management?
- What data management software and tools are you proficient in?
- How do you ensure data integrity and compliance with regulatory standards?
- Can you provide an example of a data validation process you have implemented?
- How do you handle discrepancies in clinical data?
- Describe a time when you had to collaborate with a clinical research team.
- How do you stay up-to-date with industry trends and regulatory requirements?
- What steps do you take to ensure data privacy and security?
- Can you describe your experience with database design and development?
- How do you manage multiple projects and meet deadlines?
- What is your approach to training and supporting staff on data management processes?
- Can you provide an example of a data report you have generated?
- How do you handle data audits and resolve discrepancies?
- What experience do you have with clinical trial management systems (CTMS)?
- How do you ensure accurate data entry and documentation?
- Can you describe your experience with Good Clinical Practice (GCP) guidelines?
- What technical writing experience do you have?
- How do you prepare data for submission to regulatory authorities?
- Describe a time when you identified an area for improvement in data collection processes.
- How do you coordinate with IT teams to ensure data security and backup?
