Associate Director, Clinical Data Management Quality

Iovance Biotherapeutics - San Carlos, CA

Full-time - Senior

Remote - San Carlos, CA

Chemical Manufacturing

About the position

The Associate Director, Clinical Data Management Quality at Iovance Biotherapeutics Inc. is responsible for providing technical and operational expertise to ensure the accuracy, consistency, and reliability of clinical trial data. This role involves leading and coordinating multiple projects related to the planning, execution, collection, and cleaning of clinical data, while adhering to the company's SOPs and regulatory guidelines.

Responsibilities

• Provide technical and operational expertise in clinical data management.
• Lead and coordinate functions for multiple assigned projects related to clinical data.
• Develop procedures for the CDM Quality group to maintain high-quality data throughout its lifecycle.
• Execute data validation plans to identify and address data inconsistencies and errors.
• Implement quality control measures to proactively identify and prevent data quality issues.
• Improve clinical data management processes to ensure optimal procedures.
• Perform validation activities to verify the functionality and integrity of data management systems.
• Establish and promote the use of standards in data management practices.
• Stay updated with relevant regulatory guidelines and ensure compliance.
• Document data management quality processes and procedures for regulatory audits.
• Communicate data quality issues to relevant parties, including study investigators and project management.
• Audit potential data management vendors as appropriate.
• Serve as a technical resource to colleagues and troubleshoot technical problems.
• Coordinate the transfer of clinical data between all vendors participating in a clinical study.
• Assist in the compilation of clinical data for regulatory submissions.

Requirements

• 10+ years of clinical data management experience with 4-5 years of management experience.
• Excellent verbal and written communication skills.
• Strong interpersonal skills and demonstrated ability to manage people.
• Experience with Electronic Data Capture (EDC) and other data management systems.
• Strong understanding of clinical research methodologies and regulatory requirements.
• Ability to work within budget constraints and utilize resources efficiently.