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Clinical Data Management Specialist
1 month ago
As a Clinical Data Management Specialist at Katalyst HealthCares & Life Sciences, you will be responsible for overseeing data management activities for multiple clinical studies. This includes ensuring data quality and integrity from study start-up through database lock, developing and implementing data management plans, and collaborating with clinical study teams to develop and review study protocols.
Key Responsibilities
- Develop and implement data management plans, including data validation and quality control procedures.
- Design and review case report forms (CRFs) and electronic CRFs (eCRFs) for data collection.
- Collaborate with clinical study teams to develop and review study protocols.
- Define data collection requirements and ensure alignment with study objectives and regulatory requirements.
- Coordinate with external vendors, such as central laboratories and EDC providers, to ensure timely and accurate data delivery.
- Monitor vendor performance and compliance with data management standards.
- Conduct data reviews and manage data queries to ensure data completeness, accuracy, and consistency.
- Implement and oversee data cleaning activities as specified in data management plans.
- Train internal and external staff on data management procedures, EDC systems, and study-specific requirements.
- Develop and maintain comprehensive data management documentation, including data management plans, data transfer agreements, and data review plans.
- Ensure compliance with industry standards (ICH-GCP, CDASH/CDISC) and regulatory requirements.
- Participate in regulatory submissions and inspections as needed.
- Serve as a key member of clinical study teams, providing data management expertise and support.
- Collaborate with cross-functional teams, including Biostatistics, Clinical Operations, and Medical Affairs, to ensure alignment and achieve study goals.
- Report data management metrics and study progress to stakeholders.
Requirements
- Bachelor's degree in a scientific or related field (master's degree preferred).
- Minimum of years of clinical data management experience in the biotechnology or pharmaceutical industry.
- Extensive experience with Electronic Data Capture (EDC) systems; experience with Medidata Rave preferred.
- Strong knowledge of data management processes, systems, and industry standards (ICH-GCP, CDASH/CDISC).
- Proficiency in Microsoft Office and data management software.
- Excellent organizational skills and attention to detail.
- Strong problem-solving abilities and the ability to work effectively in a team environment.
- Excellent written and verbal communication skills.
- Experience with regulatory submissions and inspections is a plus.
- Ability to travel occasionally as needed.
