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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 who will play a crucial role in ensuring the accuracy, completeness, and integrity of clinical trial data. The ideal candidate will have a strong background in clinical research, data management, and regulatory compliance. You will collaborate closely with clinical research teams, statisticians, and regulatory affairs specialists to ensure data quality and compliance with applicable standards and regulations. Your responsibilities will include designing and implementing data management plans, overseeing data collection processes, and ensuring timely and accurate data entry and validation. You will also be responsible for developing and maintaining databases, performing data quality checks, and resolving data discrepancies. Additionally, you will contribute to the preparation of clinical study reports and regulatory submissions, ensuring that all data-related documentation meets regulatory requirements and industry standards. The successful candidate will possess excellent analytical and problem-solving skills, attention to detail, and the ability to manage multiple projects simultaneously. Strong communication and interpersonal skills are essential, as you will be required to interact with cross-functional teams and external partners. You should be familiar with clinical trial protocols, electronic data capture (EDC) systems, and data management software tools. Knowledge of Good Clinical Practice (GCP), regulatory guidelines, and industry standards such as CDISC is highly desirable. As a Clinical Data Manager, you will have the opportunity to contribute significantly to the success of clinical trials and the advancement of medical research. You will be expected to stay current with emerging trends and technologies in clinical data management and continuously seek opportunities for process improvement and efficiency. This role requires a proactive individual who can work independently as well as collaboratively within a team environment. If you are passionate about clinical research, data integrity, and improving patient outcomes, we encourage you to apply for this exciting opportunity. Join our dedicated team and help us make a meaningful impact in healthcare and medical research.
Responsibilities
Text copied to clipboard!- Develop and implement clinical data management plans and procedures.
- Oversee data collection, entry, validation, and quality assurance processes.
- Ensure compliance with regulatory guidelines and industry standards.
- Collaborate with clinical research teams to resolve data discrepancies.
- Maintain and manage clinical trial databases and electronic data capture systems.
- Prepare data-related documentation for clinical study reports and regulatory submissions.
- Conduct regular data quality audits and implement corrective actions as needed.
- Provide training and support to clinical research staff on data management practices.
Requirements
Text copied to clipboard!- Bachelor's degree in life sciences, healthcare, or related field.
- Minimum of 3 years of experience in clinical data management.
- Proficiency with electronic data capture (EDC) systems and data management software.
- Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
- Strong analytical, organizational, and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Ability to manage multiple projects and meet deadlines.
- Familiarity with CDISC standards and clinical trial protocols preferred.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with electronic data capture (EDC) systems?
- How do you ensure data quality and integrity in clinical trials?
- What steps do you take when encountering data discrepancies?
- Can you explain your familiarity with regulatory guidelines and CDISC standards?
- Describe a challenging data management issue you faced and how you resolved it.
