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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 oversee the collection, processing, and validation of clinical trial data. The ideal candidate will ensure the accuracy, completeness, and consistency of data collected during clinical studies, while adhering to regulatory requirements and industry standards. This role requires strong attention to detail, excellent organizational skills, and the ability to collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs.
As a Clinical Data Manager, you will be responsible for developing data management plans, designing case report forms (CRFs), and overseeing the data entry and cleaning processes. You will also be involved in the selection and management of electronic data capture (EDC) systems and will work closely with clinical research associates and study coordinators to resolve data discrepancies. Your role is critical in ensuring that high-quality data is available for statistical analysis and regulatory submissions.
You should have a strong background in life sciences, clinical research, or a related field, and experience with clinical data management systems such as Medidata Rave, Oracle Clinical, or similar platforms. Familiarity with regulatory guidelines such as ICH-GCP, FDA 21 CFR Part 11, and CDISC standards is essential. Strong communication skills and the ability to manage multiple projects simultaneously are also key to success in this role.
This position offers the opportunity to contribute to the development of new medical treatments and to work in a dynamic and collaborative environment. If you are passionate about clinical research and data integrity, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Develop and implement data management plans for clinical trials
- Design and review case report forms (CRFs)
- Manage electronic data capture (EDC) systems
- Perform data cleaning and validation activities
- Collaborate with clinical teams to resolve data discrepancies
- Ensure compliance with regulatory standards and guidelines
- Generate and review data listings and reports
- Participate in database design and testing
- Train study personnel on data management procedures
- Support regulatory submissions with clean and accurate data
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, health informatics, or related field
- 3+ years of experience in clinical data management
- Proficiency with EDC systems such as Medidata Rave or Oracle Clinical
- Knowledge of ICH-GCP, FDA regulations, and CDISC standards
- Strong analytical and problem-solving skills
- Excellent attention to detail and organizational abilities
- Effective communication and teamwork skills
- Ability to manage multiple projects and deadlines
- Experience with data validation and query resolution
- Familiarity with SAS or other statistical software is a plus
Potential interview questions
Text copied to clipboard!- What clinical data management systems have you used?
- How do you ensure data quality and integrity in clinical trials?
- Describe your experience with regulatory compliance in data management.
- Have you worked with CDISC standards before?
- How do you handle data discrepancies during a study?
- Can you describe a challenging data issue you resolved?
- What is your experience with designing CRFs?
- How do you prioritize tasks when managing multiple studies?
- What role do you play in database lock procedures?
- How do you collaborate with cross-functional teams?
