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Iovance Biotherapeutics - San Carlos, CA
posted 2 months ago
About the position
The Clinical Data Management Quality Associate II position at Iovance Biotherapeutics Inc. is responsible for providing validation and user acceptance testing (UAT) support for Clinical Data Management activities across various studies. This role involves leading and coordinating multiple projects related to the planning, execution, collection, and cleaning of clinical data, ensuring adherence to the company's standard operating procedures (SOPs) and guidelines to maintain data integrity.
Responsibilities
- Audit potential data management vendors as appropriate.
- Serve as a technical resource to colleagues and troubleshoot technical problems.
- Assist in the compilation of clinical data for regulatory submissions.
- Assist in the development of procedures for the CDM Quality group to maintain high-quality data throughout its lifecycle.
- Develop and execute data validation plans to identify and address data inconsistencies, errors, or outliers.
- Work to improve clinical data management processes to ensure optimal procedures.
- Perform validation activities to verify the functionality and integrity of the data management systems.
- Document data management quality processes and procedures to support regulatory audits.
- Communicate data quality issues and concerns to relevant parties, including study investigators and project management.
- Perform miscellaneous duties as assigned.
Requirements
- Strong working knowledge of clinical data management systems (CDMS) and data validation tools.
- Bachelor's degree (or equivalent) in a scientific or allied health field.
- 5+ years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background.
- Excellent verbal and written communication skills and strong interpersonal skills.
- Experience with Electronic Data Capture (EDC) and other data management systems.
- Strong understanding of clinical research methodologies and regulatory requirements.
