Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
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Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
Perform data entry and cleaning activities, including discrepancy management and query resolution.
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
Collaborate with study team members to resolve data-related issues and discrepancies.
Requirements:
Bachelor’s degree in a scientific or healthcare-related field.
1 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
Proficiency in electronic data capture (EDC) systems and clinical data management software.
Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
Excellent attention to detail with problem-solving and analytical skills.
Strong organisational and time management abilities.