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Title
Text copied to clipboard!Clinical Data Specialist
Description
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We are looking for a Clinical Data Specialist to join our dynamic healthcare team. The Clinical Data Specialist plays a critical role in the collection, management, and analysis of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. This position involves working closely with clinical research teams, data managers, and biostatisticians to support the successful execution of clinical studies.
The ideal candidate will have a strong background in data management, a keen eye for detail, and a solid understanding of clinical research protocols and regulatory requirements. You will be responsible for designing and maintaining clinical databases, performing data validation, and ensuring that all data collected during clinical trials is accurate, complete, and verifiable.
In this role, you will also be expected to generate data reports, identify data trends, and contribute to the development of data management plans. You will collaborate with cross-functional teams to resolve data discrepancies and ensure timely data entry and query resolution. Familiarity with electronic data capture (EDC) systems and clinical data management systems (CDMS) is essential.
This is an excellent opportunity for someone who is passionate about clinical research and data integrity, and who thrives in a fast-paced, collaborative environment. If you are detail-oriented, analytical, and committed to improving patient outcomes through high-quality data, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Design and maintain clinical trial databases
- Perform data validation and quality control checks
- Ensure data accuracy, completeness, and compliance with protocols
- Collaborate with clinical teams to resolve data discrepancies
- Generate and review data reports and listings
- Develop and implement data management plans
- Support electronic data capture (EDC) system setup and maintenance
- Track and manage data queries and resolutions
- Ensure adherence to regulatory and industry standards
- Participate in audits and inspections as needed
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, health informatics, or related field
- 2+ years of experience in clinical data management
- Familiarity with EDC systems and CDMS tools
- Strong understanding of clinical research protocols
- Excellent attention to detail and organizational skills
- Ability to work independently and in a team environment
- Strong analytical and problem-solving abilities
- Knowledge of regulatory guidelines (e.g., GCP, FDA, ICH)
- Proficiency in Microsoft Office and data analysis tools
- Effective communication and interpersonal skills
Potential interview questions
Text copied to clipboard!- Do you have experience with electronic data capture systems?
- Can you describe your experience with clinical data validation?
- How do you ensure data accuracy and integrity in clinical trials?
- What regulatory guidelines are you familiar with?
- Have you worked with cross-functional clinical teams before?
- What data management tools have you used in previous roles?
- How do you handle data discrepancies and queries?
- Can you provide an example of a challenging data issue you resolved?
- Are you comfortable working in a fast-paced environment?
- What motivates you to work in clinical data management?
