Senior Clinical Data Manager

📋 Description

• • As a Senior Clinical Data Manager at ImmunityBio, Inc., you will be a pivotal member of our Biometrics department, leveraging your extensive expertise to ensure the integrity and accuracy of clinical trial data. This role is crucial for the successful execution of our groundbreaking cell and immunotherapy product development, aimed at transforming patient lives by empowering their natural immune systems to combat cancer and infectious diseases.
• • You will take the lead in designing, building, and maintaining clinical trial databases, utilizing Electronic Data Capture (EDC) systems to their full potential. Your responsibilities will encompass the entire data lifecycle, from initial CRF design to final database lock, ensuring compliance with internal procedures, study protocols, and industry best practices.
• • A key aspect of your role will involve creating and meticulously reviewing study-specific Case Report Forms (CRFs), whether electronic or paper-based. You will collaborate closely with the core clinical team, incorporating their input to produce high-quality CRFs in a timely and efficient manner, reflecting a deep understanding of the protocol and departmental standards.
• • You will be instrumental in configuring, migrating, and rigorously testing EDC databases. As the primary database manager for study-specific clinical teams, you will be responsible for compiling and implementing edit checks to identify and resolve data discrepancies proactively, ensuring data quality from the outset.
• • Developing detailed database requirements for EDC vendors will be a significant part of your duties. You will act as the main point of contact for vendors, ensuring timely delivery of all required data management deliverables and maintaining strong working relationships.
• • The creation and review of essential data management and database documentation will fall under your purview. This includes, but is not limited to, Data Management Plans (DMPs), CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications, all of which are critical for standardized data collection and management.
• • You will actively participate in study-specific team meetings, providing regular status reports and generating key metrics, such as query status and data trends, to keep stakeholders informed and facilitate data-driven decision-making.
• • A core responsibility involves performing thorough data reviews, generating queries for data inconsistencies, and diligently managing query closure to ensure data accuracy and completeness.
• • You will be responsible for the coding of verbatim terms, such as adverse events and concomitant medications, using standardized dictionaries like MedDRA and WHO Drug. This will involve close collaboration with medical scientists for coding consistency, review, and approval, and the subsequent incorporation of these coding files into the clinical database.
• • You will play a proactive role in the continuous improvement of our data management processes, contributing to the development of new procedures and the revision of existing ones to enhance efficiency and quality.
• • A significant part of this senior role involves mentoring and training junior staff members, sharing your expertise in clinical data management through both informal guidance and formal training sessions. You will also be responsible for training investigators and study coordinators at Investigator Meetings on CRFs, EDC systems, and completion guidelines.
• • You will serve as a subject matter expert, providing invaluable data management expertise and support to clinical teams, championing data management best practices throughout the organization.
• • Your analytical skills will be crucial in providing insights into data management strategies, advising the internal team on tactical approaches to optimize data collection and management processes.
• • You will be expected to provide work direction, guidance, and mentorship to junior data management staff, fostering their professional growth and ensuring the team's overall effectiveness.
• • Finally, you will undertake other special projects and duties as requested, demonstrating flexibility and a commitment to supporting the broader goals of the Biometrics department and ImmunityBio's mission.