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Senior Clinical Study Management Specialist
5 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob OverviewCompany BackgroundAbdera Therapeutics Inc. is at the forefront of precision oncology, pioneering next-generation targeted radiation therapies. Our innovative approach is centered around a proprietary modular technology platform designed to deliver radioisotopes that effectively target and eliminate tumor cells while preserving healthy tissue. We...
Sr Clinical Data Manager
2 months ago
Oversee data management activities for multiple clinical studies.
Ensure data quality and integrity from study start–up through database lock.
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 (e.g., 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 8years 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 (e.g., 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.
